FDA Adverse Event
Injury
Summary report: N
ENDO GIA ROTICULATOR 45-3.5 SULU
MDR report key: 1900244
·
Received November 10, 2010
Report
- Report Number
- 1219930-2010-00847
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- October 1, 2010
- Report Date
- October 5, 2010
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: LAP. RECTUM RESECTION. ACCORDING TO THE REPORTER: AFTER FIRING THE INSTRUMENT, THE SURGEON NOTICED THAT THE TISSUE WAS CUT PROPERLY BUT THE CLIPS DID NOT CLOSE PROPERLY. BY USE OF THREE ANGEL-FORMED MAGAZINES, IT HAD COME TO PRIMER LEAKAGE (OPEN DEEP RECTUM). THEN SURGEON CHANGED THE MAGAZINES TO NOT ANGEL-FORMED - THEY FUNCTIONED PROPERLY. THEREFORE, AN ADDITIONAL DEEPER RECTUM RESECTION WAS NECESSARY, WHICH HAD TO BE OVER SEWED. ADDITIONALLY A PROTECTIVE ILEO-STOMA HAD TO BE MADE. EXTENSION OF OP WAS REPORTED AS MORE THAN 30 MINUTES. CLIPS WERE RETRIEVED FROM THE PT CAVITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA ROTICULATOR 45-3.5 SULU | DISPOSABLE STAPLER | GDW | UNITED STATES SURGICAL | N6K306M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | ENDO GIA UNIVERSAL XL, LOT# N0D0715| EGIAUNIVXL| EXP DATE: 04/30/2015, MFR DATE: 04/2010 |