FDA Adverse Event
Malfunction
Summary report: N
AUTO SUTURE POWERED MULTIFIRE ENDO GIA 60-4.8 DISPOSABLE LOD
MDR report key: 120896
·
Received September 15, 1997
Report
- Report Number
- 1219930-1997-02021
- Event Type
- Malfunction
- Date Received
- September 15, 1997
- Date of Event
- August 19, 1997
- Report Date
- August 19, 1997
- 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
DEVICE NOT RECEIVED FOR EVALUATION.
Description of Event or Problem · 1
THE DEVICE WAS USED DURING A WEDGE RESECTION PROCEDURE. REPORTEDLY, THE INSTRUMENT DID NOT FIRE AND THE CARTRIDGE DISENGAGED. 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 POWERED MULTIFIRE ENDO GIA 60-4.8 DISPOSABLE LOD | DISPOSABLE SURGICAL STAPLER | GCJ | UNITED STATES SURGICAL CORPORATION | NA | N3M156 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |