FDA Adverse Event
Malfunction
Summary report: N
AUTO SUTURE ENDO CLIP L
MDR report key: 143769
·
Received January 12, 1998
Report
- Report Number
- 1219930-1998-00041
- Event Type
- Malfunction
- Date Received
- January 12, 1998
- Date of Event
- December 1, 1997
- Report Date
- December 17, 1997
- Manufacturer
- UNITED STATES SURGICAL CORP.
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION IN OUR LABORATORY FOUND A BROKEN WELD ON THE CHANNEL BRACKET. THIS CONDITION HAS BEEN ADDRESSED.
Description of Event or Problem · 1
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE JAWS SCISSORED AND THE STAPLES DID NOT FORM PROPERLY. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTO SUTURE ENDO CLIP L | DISPOSABLE CLIP APPLIER | GCJ | UNITED STATES SURGICAL CORP. | NA | N7A81 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |