FDA Adverse Event
Malfunction
Summary report: N
AUTO SUTURE*ENDO UNIVERSAL*65-4.8
MDR report key: 123837
·
Received September 26, 1997
Report
- Report Number
- 2647580-1997-01181
- Event Type
- Malfunction
- Date Received
- September 26, 1997
- Date of Event
- August 4, 1997
- Report Date
- September 2, 1997
- Manufacturer
- UNITED STATES SURGICAL CORPORATION
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
11/05/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.
Description of Event or Problem · 1
THE DEVICE WAS USED DURING AN ENDO HERNIA PROCEDURE. REPORTEDLY, THE INSTRUMENT DID NOT FIRE. 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 UNIVERSAL*65-4.8 | DISPOSABLE SURGICAL STAPLER | GCJ | UNITED STATES SURGICAL CORPORATION | NA | P7E265 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |