Education

Case serial: SCH-2021-06
Title: Disposable clip

Description

Patient Condition

  • A 64-year-old male patient with acute cholecystitis.
  • The patient was undergoing laparoscopic cholecystectomy.

Events

  • The surgeon was performing laparoscopic cholecystectomy. The first clip of the applier worked well, but when used again on the cystic duct of the gallbladder, it stopped working and there was no clip in the jaws. (* A clip applier contains 15 clips)
  • The cystic duct was torn off by the squeezed jaws of the clip applier and resulted in a leak of bile juice into the peritoneal cavity.
  • The surgeon replaced it with another clip applier (same lot number), which also failed to fire its clip. The surgeon was able to finish the surgery by replacing the clip applier to another manufacturer's product.

Post-event management & Health effect

  • The surgeon carried out an additional irrigation with 1 liter of normal saline to handle the contamination. The patient received appropriate medical treatment, including additional dose of antibiotics, but the fever continued. On the 5th day post-surgery, ultrasound and CT scans showed inflammation and necrotic changes of the common hepatic duct.
  • The surgeon performed emergency choledocho-jejunostomy for the patient and the patient fully recovered.

Investigations (Cause, Improvements)

  • The manufacturer's quality manager received two problematic clip appliers from the user, confirmed the products' defect, and reported the event to the regulatory authority.
  • The cause analysis of the defect confirmed that it was caused by an urgent change in the production plant due to a fire at the production plant that was manufacturing the clip applier.
  • The manufacturer carried out a voluntary recall for the same lot of the product.

Annex

Code

#

%

A A02 - Lower Level Codes 23 42.6%
A A05 - Lower Level Codes 18 33.3%
A A01 - Lower Level Codes 2 3.7%
A A04 - Lower Level Codes 2 3.7%
A A15 - Lower Level Codes 2 3.7%
A A17 , A23 , A06 , A07 , A08 , A11 , A14 7
total:54
13.0%
B B01 - Lower Level Codes 17 44.7%
B B02 - Lower Level Codes 8 21.1%
B B03 - Lower Level Codes 6 15.8%
B B04 - Lower Level Codes 3 7.9%
B B05 - Lower Level Codes 2 5.3%
B B09 , B13 2
total:38
5.3%
C C16 - Lower Level Codes 24 55.8%
C C06 - Lower Level Codes 5 11.6%
C C01 - Lower Level Codes 5 11.6%
C C07 - Lower Level Codes 2 4.7%
C C03 - Lower Level Codes 2 4.7%
C C04 , C05 , C09 , C13 , C23 5
total:43
11.6%
D D03 - Lower Level Codes 31 77.5%
D D01 - Lower Level Codes 4 10.0%
D D10 - Lower Level Codes 2 5.0%
D D06 - Lower Level Codes 1 2.5%
D D13 - Lower Level Codes 1 2.5%
D D04 1
total:40
2.5%
E E11 - Lower Level Codes 20 40.0%
E E10 - Lower Level Codes 7 14.0%
E E19 - Lower Level Codes 6 12.0%
E E20 - Lower Level Codes 4 8.0%
E E21 - Lower Level Codes 4 8.0%
E E05 , E12 , E13 , E01 , E03 , E23 , E04 , E07 9
total:50
18.0%
F F08 - Lower Level Codes 14 21.2%
F F19 - Lower Level Codes 14 21.2%
F F12 - Lower Level Codes 10 15.2%
F F05 - Lower Level Codes 10 15.2%
F F07 - Lower Level Codes 4 6.1%
F F23 , F06 , F01 , F14 , F18 , F02 , F27 , F04 14
total:66
21.2%
G G04 - Lower Level Codes 26 72.2%
G G06 - Lower Level Codes 5 13.9%
G G07 - Lower Level Codes 2 5.6%
G G01 - Lower Level Codes 1 2.8%
G G02 - Lower Level Codes 1 2.8%
G G03 1
total:36
2.8%

Hierachy is important.

Soo Jeong Choi , Republic of Korea
[ 2021-09-04 09:17:16.0]

C0603 and C0602 are confusing!

[2]

Additional treatment, drug intake and prolong hospitalization

Yen Fu Lee , Chinese Taipei
[ 2021-09-06 17:38:50.0]

That's why I put three F categories.

[1]

problematic clip

María Eugenia Villalobos-Hernández , (Non-APEC) Costa Rica
[ 2021-09-12 03:07:04.0]

This case gives very important lesson learned to manufactures, any change in manufacturing process should be double controlled in order to assure quality, and prevent any risk to patients.

[1]
You Kyoung Lee , Republic of Korea [ 2021-09-13 16:01:22.0]

Hundred percent agree!

Disposable clip

Jiyun Jeong , Republic of Korea
[ 2021-09-13 15:38:50.0]

Manufacturing Process Problem Identified

[0]

it was good activities by QMS

Jang Soonheung , Republic of Korea
[ 2021-09-15 11:16:09.0]

it was good activities by QMS

[0]

Disposable clip

Stevie Lee , Republic of Korea
[ 2021-09-16 15:15:06.0]

It was a very good activity

[0]

Disposable clip

Wanida Kaewpanukrungsi , Thailand
[ 2021-09-17 14:44:04.0]

A good example of voluntary recall action.

[0]

Cause Traced to Manufacturing

Erika Masis , (Non-APEC) Costa Rica
[ 2021-09-20 12:38:40.0]

Manufacturing Deficiency in the disposable clip

[1]

it was good activities by QMS

Jiyeon Kin , Republic of Korea
[ 2021-09-21 23:26:32.0]

it was good activities by QMS

[0]

Disposable Clip

Aidahwaty Olaybal , Malaysia
[ 2021-09-22 13:15:41.0]

this is good activity for us to understand the QMS Activity.

[0]