FDA Adverse Event
Injury
Summary report: N
GIA UNIVERSAL
MDR report key: 2161192
·
Received July 1, 2011
Report
- Report Number
- 1219930-2011-00536
- Event Type
- Injury
- Date Received
- July 1, 2011
- Date of Event
- May 31, 2011
- Report Date
- June 22, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: UROLOGICAL. ACCORDING TO THE REPORTER: THE DEVICE JAMMED ON THE TISSUES AND THE KNIFE BLADE DID NOT RETURN TO ITS ORIGINAL POSITION. THE SURGEON HAD TO CLIP AROUND THE AREA TO BE ABLE TO REMOVE THE INSTRUMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GIA UNIVERSAL | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | UNITED STATES SURGICAL | N0F0349 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | LOT # N8E45A| MANUF. 05/2008, EXP. 05/31/2013, K061095| ENDO GIA ROTICULATOR 30-2.5 SULU, CATALOG#:030451 |