FDA Adverse Event
Injury
Summary report: N
ENDO GIA UNIVERSAL 12 MM SINGLE USE INST
MDR report key: 1161883
·
Received August 13, 2008
Report
- Report Number
- 1219930-2008-00609
- Event Type
- Injury
- Date Received
- August 13, 2008
- Date of Event
- June 24, 2008
- Report Date
- August 5, 2008
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GDW
- PMA / PMN Number
- k061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PROCEDURE: THORACOSCOPY. ACCORDING TO THE RPTR: THE PT WAS HAVING A RIGHT UPPER LOBE LUNG WEDGE RESECTION WITH INSERTION OF BEADS. DURING THE PROCEDURE, 3 OF THE 4 ENDOSCOPIC GUNS BROKE IN THE 3 SMALL PIECES OF METAL CAME OFF OF THE 3 "RELOADS FOR STAPLERS". TWO OF THE METAL PIECES WERE IMMEDIATELY FOUND AND FOLLOWING AN X-RAY FILM OF THE CHEST, THE THIRD PIECE WAS LOCATED IN THE RIGHT LOWER LUNG AREA. THE SURGEON MADE THE DECISION AT THAT TIME NOT TO REOPEN THE PT TO ATTEMPT RETRIEVAL. THE PT IS AWARE OF THE RETAINED PIECE OF METAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA UNIVERSAL 12 MM SINGLE USE INST | DISPOSABLE STAPLING DEVICE | GDW | NORTH HAVEN - USS | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Other | 030415, ENDO GIA II 60-4.8 SULU |