FDA Adverse Event
Injury
Summary report: N
EGIA ULTRA UNIVERSAL STAPLER
MDR report key: 2202447
·
Received August 5, 2011
Report
- Report Number
- 1219930-2011-00660
- Event Type
- Injury
- Date Received
- August 5, 2011
- Date of Event
- June 16, 2011
- Report Date
- July 22, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K083519
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: HEMICOLECTOMY. ACCORDING TO THE REPORTER: THE FIRST SULU PLACED MALFORMED STAPLES, NOT THE PROPER B-SHAPE. IN THE BOX, THERE IS ALSO A MISFORMED STAPLE. AFTER THAT, THEY USED ANOTHER SULU THAT CORRECTLY PLACED PROPER B-SHAPED STAPLES. A SMALL PIECE OF COLON WAS RESECTED DUE TO THE PRODUCT PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EGIA ULTRA UNIVERSAL STAPLER | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | UNITED STATES SURGICAL | N1E00674UKX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | MANUF: 05/2010, EXP: 05/31/2015| ENDO GIA ROTICULATOR 45-3.5 SULU: CATALOG #:030455| LOT: N0E0355, K061095 |