FDA Adverse Event
Other
Summary report: N
PRECISE PI-55 MEDIUM
MDR report key: 34602
·
Received June 26, 1996
Report
- Report Number
- 34602
- Event Type
- Other
- Date Received
- June 26, 1996
- Date of Event
- March 27, 1996
- Report Date
- June 26, 1996
- Manufacturer
- 3M HEALTH CARE CORP.
- Product Code
- GAG
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- NY, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
STAPLER WAS FIRED. STAPLES WERE RELEASED BUT NOT CRIMPED. BECAUSE OF LIMITED BOWEL TISSUE ANOTHER ANASTAMOSIS COULD NOT BE ATTEMPTED. PERMANENT COLOSTOMY DONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISE PI-55 MEDIUM | DISPOSABLE SURGICAL STAPLER | GAG | 3M HEALTH CARE CORP. | 4903 1 | 1029 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Other |