FDA Adverse Event
Injury
Summary report: N
ENDO GIA ROTICULATOR 45-3.5 SULU
MDR report key: 2202446
·
Received August 5, 2011
Report
- Report Number
- 1219930-2011-00656
- Event Type
- Injury
- Date Received
- August 5, 2011
- Report Date
- July 25, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: LAP APPENDECTOMY. ACCORDING TO THE REPORTER: MALFORMED STAPLING OCCURRED ON THE ROOT PART OF THE CARTRIDGE. ANOTHER DEVICE WAS USED TO FINISH THE PROCEDURE. NO BLEEDING OCCURRED. NOTHING FELL INTO THE PT CAVITY. ADDITIONAL RESECTION OF TISSUE WAS REQUIRED. OPERATIVE TIME WAS NOT EXTENDED MORE THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA ROTICULATOR 45-3.5 SULU | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | UNITED STATES SURGICAL | N0L0742L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |