FDA Adverse Event
Injury
Summary report: N
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
MDR report key: 3001318
·
Received March 5, 2013
Report
- Report Number
- 1219930-2013-00178
- Event Type
- Injury
- Date Received
- March 5, 2013
- Date of Event
- January 16, 2013
- Report Date
- February 11, 2013
- Manufacturer
- COVIDIEN, FORMERLY US SUR
- Product Code
- GDW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: BOWEL RESECTION. ACCORDING TO THE REPORTER THE SURGEON PLACED STAPLER ON BOWEL AND LOCKED INTO PLACE THEN COULD NOT RELEASE FROM BOWEL. THE SURGEON HAD TO CUT AROUND LOCKED STAPLER SO SHE COULD RELEASE IT AND PULL THRU TROCAR. NO REINFORCEMENT MATERIAL USED IN CONJUNCTION WITH THE STAPLING DEVICE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 94201 | ENDO GIA UNIVERSAL 12MM SINGLE USE INST | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | COVIDIEN, FORMERLY US SUR | N1L0793X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Other | ENDO GIA ROTICULATOR 30-3.5 SULU: (B)(4) |