FDA Adverse Event
Malfunction
Summary report: N
AUTO SUTURE*MULTIFIRE ENDO GIA*30-3.5
MDR report key: 124116
·
Received September 30, 1997
Report
- Report Number
- 2647580-1997-01215
- Event Type
- Malfunction
- Date Received
- September 30, 1997
- Date of Event
- September 2, 1997
- Report Date
- September 8, 1997
- Manufacturer
- UNITED STATES SURGICAL CORPORATION
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
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 A LAVH PROCEDURE. REPORTEDLY, THE INSTRUMENT WAS DIFFICULT TO CLOSE AND 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*MULTIFIRE ENDO GIA*30-3.5 | DISPOSABLE SURGICAL STAPLER | GCJ | UNITED STATES SURGICAL CORPORATION | NA | P7G101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |