FDA Adverse Event
Malfunction
Summary report: N
AUTO SUTURE ENDO CLIP 5MM
MDR report key: 146250
·
Received January 26, 1998
Report
- Report Number
- 1219161-1998-00200
- Event Type
- Malfunction
- Date Received
- January 26, 1998
- Date of Event
- November 28, 1997
- Report Date
- November 28, 1997
- Manufacturer
- UNITED STATES SURGICAL CORP.
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
08/06/1999. SUPPLEMENTAL #2 SENT TO FDA. DEVICE NOT AVAILABLE FOR EVALUATION.
Description of Event or Problem · 1
THE PRODUCT WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT LOAD 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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |