FDA Adverse Event
Malfunction
Summary report: N
AUTO SUTURE ENDO UNIVERSAL 65-4.0
MDR report key: 147316
·
Received February 3, 1998
Report
- Report Number
- 2647580-1998-00103
- Event Type
- Malfunction
- Date Received
- February 3, 1998
- Date of Event
- December 22, 1997
- Report Date
- January 6, 1998
- Manufacturer
- UNITED STATES SURGICAL CORPORATION
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
1/25/1999- SUPPLEMENTAL REPORT SENT TO FDA.
Description of Event or Problem · 1
THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED NO PATIENT INJURY OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTO SUTURE ENDO UNIVERSAL 65-4.0 | DISPOSABLE SURGICAL STAPLER | GCJ | UNITED STATES SURGICAL CORPORATION | NA | P7J315 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |