FDA Adverse Event
Injury
Summary report: N
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
MDR report key: 1023297
·
Received April 1, 2008
Report
- Report Number
- 1219930-2008-00256
- Event Type
- Injury
- Date Received
- April 1, 2008
- Date of Event
- January 25, 2008
- Report Date
- March 31, 2008
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GAG
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PROCEDURE: COLECTOMY. ACCORDING TO THE REPORTER: THE DEVICE MADE A CREAKING NOISE AND THE SULU CANNOT BE CLOSED. TEN DIFFERENT SULUS WERE USED AND THE OPERATION LASTED 6 HRS 15MN. THE OPERATION TIME WAS INCREASE BY MORE THAN 1/2 HOUR, THE STAPLERS WERE APPLIED BUT THERE WAS NO STAPLING AS THE LOADING UNITS WOULD NOT CLOSE COMPLETELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA UNIVERSAL 12MM SINGLE USE INST | SURGICAL STAPLING DEVICE | GAG | NORTH HAVEN - USS | N7K97 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other | ENDO GIA ROTICULATOR 60-3.5| 030458| EXPIRATION DATE: 09/30/2012 |