Education

Case serial: SCH-2021-02
Title: Disposable handpiece of electrosurgical unit

Description

Patient Condition

  • A 66-year-old male patient with peritonitis accompanied by acute appendicitis.
  • The patient was under laparoscopic surgery.

Events

  • When the surgeon pressed the coagulation button to stop the bleeding using an electrosurgical unit (ESU), cutting occured on the procedure area.

Post-event management & Health effect

  • After becoming aware of the event, the surgeon took relevant actions and completed the surgery using another handpiece of electrosurgical unit from the same manufacturer.
  • The surgery took 1.5 times longer than usual. The patient recovered without any particular complications.

Investigations (Cause, Improvements)

  • After investigating the problematic product, the investigator from the manufacturer confirmed that the coagulation button was connected to turn on the cutting output from ESU to tip of the handpiece and vice versa.
  • It is guessed that the accident occurred because the misassembled product could not be filtered out during the manufacturing inspection process. However, the nurse, who has pre-tested the handpiece could not recall whether the visual and audible display on the ESU worked accordingly with the mode of the handpiece button. Also, there is no routine pre-testing to check the ESU's output, because it is not feasible in practice during surgery.
  • Manufacturing aspect: Re-evaluate the manufacturing process and strengthen the inspection process of the final products.
  • User aspect; Audible or visual display of the ESU and ESU output to be double-checked by the assistant surgeon.

Click to Zoom

Annex

Code

#

%
A A02 - Lower Level Codes 34 41.5%
A A01 - Lower Level Codes 9 11.0%
A A05 - Lower Level Codes 8 9.8%
A A23 - Lower Level Codes 8 9.8%
A A07 - Lower Level Codes 5 6.1%
A A09 , A22 , A26 , A12 , A15 , A03 , A27 , A16 , A20 , A21 18
total:82 		22.0%
B B01 - Lower Level Codes 39 75.0%
B B02 - Lower Level Codes 5 9.6%
B B04 - Lower Level Codes 2 3.8%
B B03 - Lower Level Codes 1 1.9%
B B05 - Lower Level Codes 1 1.9%
B B09 , B11 , B13 , B14 4
total:52		 7.7%
C C16 - Lower Level Codes 23 39.0%
C C02 - Lower Level Codes 10 16.9%
C C13 - Lower Level Codes 8 13.6%
C C04 - Lower Level Codes 6 10.2%
C C23 - Lower Level Codes 4 6.8%
C C07 , C01 , C17 , C18 8
total:59		 13.6%
D D03 - Lower Level Codes 38 60.3%
D D01 - Lower Level Codes 7 11.1%
D D02 - Lower Level Codes 4 6.3%
D D11 - Lower Level Codes 4 6.3%
D D09 - Lower Level Codes 3 4.8%
D D07 , D08 , D04 , D06 , D13 7
total:63		 11.1%
E E20 - Lower Level Codes 12 25.0%
E E24 - Lower Level Codes 9 18.8%
E E05 - Lower Level Codes 7 14.6%
E E10 - Lower Level Codes 7 14.6%
E E03 - Lower Level Codes 5 10.4%
E E21 , E04 , E06 , E08 , E01 8
total:48		 16.7%
F F05 - Lower Level Codes 19 35.2%
F F19 - Lower Level Codes 9 16.7%
F F06 - Lower Level Codes 4 7.4%
F F11 - Lower Level Codes 3 5.6%
F F14 - Lower Level Codes 3 5.6%
F F01 , F02 , F26 , F12 , F23 , F07 , F08 , F13 16
total:54		 29.6%
G G02 - Lower Level Codes 20 36.4%
G G04 - Lower Level Codes 20 36.4%
G G06 - Lower Level Codes 9 16.4%
G G01 - Lower Level Codes 2 3.6%
G G05 - Lower Level Codes 2 3.6%
G G03 , G07 2
total:55		 3.6%

The surgery took 1.5 times longer than usual. The patient recovered without any particular complications.

Ju min Park , Republic of Korea
[ 2021-09-01 13:50:13.0]

Why did it take 1.5 times longer than usual? There were no complications, but I'm curious as to why it took more time.

[0]

1.5 times longer than usual.

Soo Jeong Choi , Republic of Korea
[ 2021-09-04 06:58:25.0]

If I was a surgeon. It would be serious event. Codes for clinical investigation and component (especially D& G) were not easy for me.

[0]

Sub Coordinator of Standardization

Jojor, S.Si., Apt., M.Si - , Indonesia
[ 2021-09-08 13:30:32.0]

The risks that occur during the use of any medical device can be caused from various sides, it can be from the user (operator) or manufacturer or from the conditions in which the device is used, so that everyone who comes into contact with the medical device must always do it correctly and carefully according to the instructions for use or conditions specified by the manufacturer

[0]

Every medical device has it's own risk so it must be trated or used carefully dan appropriately

Jojor, S.Si., Apt., M.Si - , Indonesia
[ 2021-09-08 13:33:36.0]

The risks that occur during the use of any medical device can be caused from various sides, it can be from the user (operator) or manufacturer or from the conditions in which the device is used, so that everyone who comes into contact with the medical device must always do it correctly and carefully according to the instructions for use. or conditions specified by the manufacturer

[1]

Every medical device has it's own risk so it must be treated or used carefully dan appropriately

Jojor, S.Si., Apt., M.Si - , Indonesia
[ 2021-09-08 13:35:06.0]

The risks that occur during the use of any medical device can be caused from various sides, it can be from the user (operator) or manufacturer or from the conditions in which the device is used, so that everyone who comes into contact with the medical device must always treat or use it in correctly and carefully, according to the instructions for use or conditions specified by the manufacturer

[1]

check device functionally

María Eugenia Villalobos-Hernández , (Non-APEC) Costa Rica
[ 2021-09-11 09:05:47.0]

It is need to evaluate the functionally of any device before surgeon, especially if there is no other device available

[1]

User training

María Eugenia Villalobos-Hernández , (Non-APEC) Costa Rica
[ 2021-09-12 02:31:09.0]

To me it is very important to include training to potential users, so we can prevent situations like it shown in this case

[1]

Disposable handpiece of electrosurgical unit

Jiyun Jeong , Republic of Korea
[ 2021-09-13 15:44:35.0]

Operational Problem Identified- Device Difficult to Operate

[0]

device function

Pei-Hsuan Huang , The United States
[ 2021-09-14 04:31:50.0]

Check device function

[0]

Electrosurgical Unit dysfunction

SoonWoo Hong , Republic of Korea
[ 2021-09-14 16:33:17.0]

It is helpful to check the adverse events of the Electrosurgical Unit.

[0]

Disposable handpiece of electrosurgical unit

Stevie Lee , Republic of Korea
[ 2021-09-16 12:26:43.0]

It is very helpful activity.

[0]

Doubt when completing annex F

Daisy Marín Mora , (Non-APEC) Costa Rica
[ 2021-09-16 13:57:39.0]

I had difficulty assigning Annex F in this case

[0]

Double check

María Del Rocío Peinador Roldán , (Non-APEC) Costa Rica
[ 2021-09-16 23:48:54.0]

Double cheking in a context of a malfunctioning device event is not going too far as instructions to the users?

[0]

Malfunction of electrosurgical unit

Jin Kuk Kim , Republic of Korea
[ 2021-09-17 17:37:48.0]

Malfunction of electrosurgical unit is a really dangerous situation in clinical setting.

[0]

Electrosurgical Unit dysfunction

Erika Masis , (Non-APEC) Costa Rica
[ 2021-09-20 09:53:43.0]

It is helpful to check the adverse events of the Electrosurgical Unit.

[1]

Malfunction of electrosurgical unit

Erika Masis , (Non-APEC) Costa Rica
[ 2021-09-20 10:38:16.0]

Malfunction of electrosurgical unit is a really dangerous situation in clinical setting.

[2]

Electrosurgical Unit Malfunction

Jieun Lee , Republic of Korea
[ 2021-09-20 21:01:08.0]

All devices involved with the surgery must be evaluated routinely. It is vital to make such procedure a standard practice, in order to report any anomaly in surgical devices and prevent adverse events.

[0]

ESU Malfunction

Citra Bonnita Putri , Indonesia
[ 2021-09-21 00:48:14.0]

This activity is very helpful.

[0]

Disposable handpiece of electrosurgical unit

Regina Li , Hong Kong
[ 2021-09-21 11:14:20.0]

This is a very helpful case.

[0]

Disposable handpiece of electrosurgical unit

Seontae Kim , Republic of Korea
[ 2021-09-21 17:33:04.0]

Helpful case

[0]

This activity is very helpful.

Jiyeon Kin , Republic of Korea
[ 2021-09-21 23:13:35.0]


This activity is very helpful.

[0]

Disposable handpiece

Aidahwaty Olaybal , Malaysia
[ 2021-09-22 13:21:20.0]

The cause of malfunction electrosurgical is dangerous and need to be scrutiny by the manufacturer.

[0]

Disposable handpiece of electrosurgical unit

Mikyoung An , Republic of Korea
[ 2021-09-22 18:42:54.0]

Device Difficult to Operate

[1]