FDA Adverse Event
Malfunction
Summary report: N
AUTO SUTURE ENDO UNIVERSAL 65-4.0
MDR report key: 121705
·
Received September 19, 1997
Report
- Report Number
- 2647580-1997-01142
- Event Type
- Malfunction
- Date Received
- September 19, 1997
- Date of Event
- August 13, 1997
- Report Date
- August 25, 1997
- Manufacturer
- UNITED STATES SURGICAL CORPORATION
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
11/06/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.
Description of Event or Problem · 1
THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA PROCEDURE. REPORTEDLY, THE INSTRUMENT BROKE AND A COMPONENT DISENGAGED INTO PT'S CAVITY. THE SURGEON WAS ABLE TO RETRIEVE THE COMPONENT WITHOUT PT INJURY AND USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE.
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 | P7C266 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |