FDA Adverse Event
Injury
Summary report: N
MULTIFIRE ENDO GIA 30-2.5 (V) 12MM STAPLE
MDR report key: 1111025
·
Received August 12, 2008
Report
- Report Number
- 2647580-2008-00464
- Event Type
- Injury
- Date Received
- August 12, 2008
- Date of Event
- August 7, 2008
- Report Date
- August 11, 2008
- Manufacturer
- PONCE - USS
- Product Code
- GDW
- PMA / PMN Number
- K900129
- 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: LOBECTOMY. ACCORDING TO THE REPORTER: ON THE THIRD FIRING TO THE BRONCHUS, THE DEVICE FAILED O CUT TISSUE. STAPLING WAS SUCCESSFUL. ANOTHER MULTIFIRE ENDO GIA WAS APPLIED. AFTER FIRING, IT WAS CONFIRMED THAT THE RELEASE BUTTON WAS MISSING FROM THE INSTRUMENT. THE SURGEON SEARCHED THE PT CAVITY AND TOOK AN X-RAY. HOWEVER, THE MISSING COMPONENT WAS NOT FOUND INSIDE THE PT, SO THE PROCEDURE WAS COMPLETED. NO TISSUE DAMAGE OR BLEEDING WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTIFIRE ENDO GIA 30-2.5 (V) 12MM STAPLE | DISPOSABLE STAPLING DEVICE | GDW | PONCE - USS | P7A0615 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Other | 030807 |