FDA Adverse Event
Malfunction
Summary report: N
AUTO SUTURE GIA 50 PREMIUM 3.8 DISPOSABLE LOADING UNIT
MDR report key: 118304
·
Received September 4, 1997
Report
- Report Number
- 1219930-1997-01958
- Event Type
- Malfunction
- Date Received
- September 4, 1997
- Date of Event
- January 9, 1997
- Report Date
- January 27, 1997
- Manufacturer
- UNITED STATES SURGICAL CORP.
- Product Code
- GAG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
12/03/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.
Description of Event or Problem · 1
THE DEVICE WAS USED DURING A HEMICOLECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT DID NOT STAPLE. THE SURGEON MANUALLY SUTURED 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 GIA 50 PREMIUM 3.8 DISPOSABLE LOADING UNIT | DISPOSABLE SURGICAL STAPLER | GAG | UNITED STATES SURGICAL CORP. | NA | N6D195 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |