FDA Adverse Event
Injury
Summary report: N
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
MDR report key: 2221571
·
Received August 18, 2011
Report
- Report Number
- 1219930-2011-00705
- Event Type
- Injury
- Date Received
- August 18, 2011
- Date of Event
- July 16, 2011
- Report Date
- August 2, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: LAPAROSCOPIC APPENDECTOMY. ACCORDING TO THE REPORTER: THE DEVICE FIRED BUT WOULD NOT RELEASE THE JAWS AFTER IT WAS FIRED. THE SURGEON USED A LIGASURE TO CUT THE DEVICE OUT. THE DEVICE WAS STILL ATTACHED TO THE HAND INSTRUMENT. MORE TISSUE THAN EXPECTED WAS TAKEN OUT DUE TO THE USE OF THE LIGASURE TO FREE THE INSTRUMENT FROM TISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA UNIVERSAL 12MM SINGLE USE INST | DISPOSABLE SURGICAL STAPLING INSTRU | GDW | UNITED STATES SURGICAL | N1B0669X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | MANUF: 08/2010, (B)(4)| ENDO GIA ROTICULATOR 60-2.5 SULU: CAT #030457| LOT: N0H0284, EXP: 08/31/2015, |