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
A02 |
Manufacturing, Packaging or Shipping Problem |
15 |
|
A0201 |
Product Quality Problem |
1 |
|
A020102 |
Nonstandard Device |
1 |
|
A0202 |
Defective Component |
1 |
|
A0203 |
Defective Device |
4 |
|
A020601 |
Component Misassembled |
1 |
|
|
23
|
42.6%
|
A |
A05 - Lower Level Codes
A05 |
Mechanical Problem |
9 |
|
A0503 |
Ejection Problem |
3 |
|
A0505 |
Firing Problem |
1 |
|
A050501 |
Failure to Fire |
2 |
|
A050704 |
Failure to Form Staple |
1 |
|
A051104 |
Difficult to Open or Close |
1 |
|
A051201 |
Device Dislodged or Dislocated |
1 |
|
|
18
|
33.3%
|
A |
A15 - Lower Level Codes
A15 |
Activation, Positioning or Separation Problem |
2 |
|
|
2
|
3.7%
|
A |
A01 - Lower Level Codes
A01 |
Patient Device Interaction Problem |
2 |
|
|
2
|
3.7%
|
A |
A04 - Lower Level Codes
A04 |
Material Integrity Problem |
2 |
|
|
2
|
3.7%
|
A |
A14 , A17 , A23 , A06 , A07 , A08 , A11 |
7 total:54
|
13.0%
|
B |
B01 - Lower Level Codes
B01 |
Testing of Actual/Suspected Device |
17 |
|
|
17 |
44.7%
|
B |
B02 - Lower Level Codes
B02 |
Testing of Device from Same Lot/Batch Retained by Manufacturer |
8 |
|
|
8 |
21.1%
|
B |
B03 - Lower Level Codes
B03 |
Testing of Device from Same Lot/Batch Returned from User |
6 |
|
|
6 |
15.8%
|
B |
B04 - Lower Level Codes
B04 |
Testing of Device from Other Lot/Batch Retained by Manufacturer |
3 |
|
|
3 |
7.9%
|
B |
B05 - Lower Level Codes
B05 |
Testing of Device from Other Lot/Batch Returned From User |
2 |
|
|
2 |
5.3%
|
B |
B13 , B09 |
2 total:38 |
5.3%
|
C |
C16 - Lower Level Codes
C16 |
Manufacturing Process Problem Identified |
19 |
|
C1601 |
Assembly Problem Identified |
4 |
|
C1604 |
Maintenance of Manufacturing Machinery |
1 |
|
| 24 |
55.8%
|
C |
C01 - Lower Level Codes
C01 |
Biological Problem Identified |
1 |
|
C0101 |
Biocompatibility Problem Identified |
2 |
|
C0104 |
Cytotoxicity Problem Identified |
1 |
|
C0107 |
Unintended Presence of Allergens |
1 |
|
| 5 |
11.6%
|
C |
C06 - Lower Level Codes
C06 |
Material and/or Chemical Problem Identified |
3 |
|
C060201 |
Improper Composition/ Concentration |
1 |
|
C0603 |
Inadequate Physicochemical Properties |
1 |
|
| 5 |
11.6%
|
C |
C03 - Lower Level Codes
C03 |
Electromagnetic Compatibility Problem Identified |
1 |
|
C0303 |
Inadequate Immunity |
1 |
|
| 2 |
4.7%
|
C |
C07 - Lower Level Codes
C07 |
Mechanical Problem Identified |
2 |
|
| 2 |
4.7%
|
C |
C04 , C05 , C09 , C13 , C23 |
5 total:43 |
11.6%
|
D |
D03 - Lower Level Codes
D03 |
Cause Traced to Manufacturing |
19 |
|
D0301 |
Manufacturing Deficiency |
6 |
|
D0302 |
Quality Control Deficiency |
6 |
|
| 31 |
77.5%
|
D |
D01 - Lower Level Codes
D01 |
Cause Traced to Device Design |
4 |
|
| 4 |
10.0%
|
D |
D10 - Lower Level Codes
D10 |
Cause Traced to Non-Device Related Factors |
1 |
|
D1002 |
Adverse Event Related to Procedure |
1 |
|
| 2 |
5.0%
|
D |
D04 - Lower Level Codes
D04 |
Cause Traced to Transport/Storage |
1 |
|
| 1 |
2.5%
|
D |
D06 - Lower Level Codes
D06 |
Cause Traced to Environment |
1 |
|
| 1 |
2.5%
|
D |
D13 |
1 total:40 |
2.5%
|
E |
E11 - Lower Level Codes
E11 |
Hepatic and Biliary System |
14 |
|
E1102 |
Hepatitis |
3 |
|
E1107 |
Unspecified Hepatic or Biliary Problem |
3 |
|
| 20 |
40.0%
|
E |
E10 - Lower Level Codes
E10 |
Gastrointestinal System |
5 |
|
E1024 |
Peritonitis |
2 |
|
| 7 |
14.0%
|
E |
E19 - Lower Level Codes
| 6 |
12.0%
|
E |
E20 - Lower Level Codes
E20 |
Injury |
2 |
|
E2009 |
Laceration(s) |
1 |
|
E2012 |
Post Traumatic Wound Infection |
1 |
|
| 4 |
8.0%
|
E |
E21 - Lower Level Codes
E21 |
Procedural Complications |
2 |
|
E211401 |
Internal Organ Perforation |
1 |
|
E2115 |
Post Operative Wound Infection |
1 |
|
| 4 |
8.0%
|
E |
E05 , E12 , E13 , E01 , E03 , E23 , E04 , E07 |
9 total:50 |
18.0%
|
F |
F08 - Lower Level Codes
F08 |
Hospitalization or Prolonged Hospitalization |
13 |
|
F0801 |
Intensive Care |
1 |
|
| 14 |
21.2%
|
F |
F19 - Lower Level Codes
F19 |
Surgical Intervention |
7 |
|
F1901 |
Additional Surgery |
6 |
|
F1906 |
Modified Surgical Procedure |
1 |
|
| 14 |
21.2%
|
F |
F05 - Lower Level Codes
F05 |
Delay to Treatment/ Therapy |
10 |
|
| 10 |
15.2%
|
F |
F12 - Lower Level Codes
F12 |
Serious Injury/ Illness/ Impairment |
7 |
|
F1203 |
Life Threatening Illness or Injury |
3 |
|
| 10 |
15.2%
|
F |
F07 - Lower Level Codes
F07 |
Exacerbation of Existing Condition |
4 |
|
| 4 |
6.1%
|
F |
F23 , F06 , F01 , F04 , F14 , F18 , F02 , F27 |
14 total:66 |
21.2%
|
G |
G04 - Lower Level Codes
G04 |
Mechanical |
14 |
|
G04006 |
Applicator |
1 |
|
G04021 |
Carrier |
1 |
|
G04044 |
Device Deployer |
1 |
|
G04047 |
Ejector |
1 |
|
G0405204 |
Clip |
4 |
|
G04077 |
Jaw |
2 |
|
G04129 |
Tip |
1 |
|
G04130 |
Tool |
1 |
|
| 26 |
72.2%
|
G |
G06 - Lower Level Codes
| 5 |
13.9%
|
G |
G07 - Lower Level Codes
G07 |
Others |
1 |
|
G07002 |
Appropriate Term/Code Not Available |
1 |
|
| 2 |
5.6%
|
G |
G01 - Lower Level Codes
G01 |
Biological and Chemical |
1 |
|
| 1 |
2.8%
|
G |
G02 - Lower Level Codes
G02 |
Electrical and Magnetic |
1 |
|
| 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]
|
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