FDA Adverse Event
Injury
Summary report: N
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
MDR report key: 1111024
·
Received August 12, 2008
Report
- Report Number
- 1219930-2008-00608
- Event Type
- Injury
- Date Received
- August 12, 2008
- Date of Event
- August 5, 2008
- Report Date
- August 12, 2008
- Manufacturer
- NORTH HAVEN - USS
- 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
INITIAL REPORT SENT TO FDA ON 08/12/2008.
Description of Event or Problem · 1
PROCEDURE: THORACO/WEDGE/SEGMENTAL RESECTION. ACCORDING TO THE REPORTER: THE FIRST AND SECOND FIRING WERE PERFORMED WITH ENDO GIA II 60-4.8 SULU AND WERE WELL COMPLETED. DURING THE THIRD FIRE WITH AN ENDO GIA II 60-3.5 SULU, A CRACKING SOUND WAS HEARD AND THE ANVIL WAS BENT. ON THE FOURTH FIRE WITH AN ENDO GIA II 60-3.5 SULU, THE CARTRIDGE BROKE. THE TISSUE WAS TREATED WITH ANOTHER DEVICE. AFTER THAT, WHILE IRRIGATING THE CAVITY, A COMPONENT WAS FOUND INSIDE THE CAVITY AND WAS RETRIEVED. THE PROCEDURE WAS COMPLETED LAPAROSCOPICALLY. BLEEDING REPORTED AS OVER 500CC. PT STATUS WAS REPORTED AS OK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA UNIVERSAL 12MM SINGLE USE INST | DISPOSABLE STAPLING DEVICE | GDW | NORTH HAVEN - USS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | 030414 |