FDA Adverse Event
Malfunction
Summary report: N
AUTO SUTURE ENDO CLIP 5MM
MDR report key: 156949
·
Received March 12, 1998
Report
- Report Number
- 1219161-1998-00444
- Event Type
- Malfunction
- Date Received
- March 12, 1998
- Date of Event
- February 11, 1998
- Report Date
- February 11, 1998
- Manufacturer
- UNITED STATES SURGICAL CORP.
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
UPON RE-REVIEW IT WAS DETERMINED THAT THIS FTR#9801653 IS A DUPLICATE FILE PREVIOUSLY SUBMITTED.
Description of Event or Problem · 1
THE PRODUCT WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT ADVANCE 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 5MM | DISPOSABLE CLIP APPLIER | GCJ | UNITED STATES SURGICAL CORP. | NA | U7H07 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |