FDA Adverse Event
Injury
Summary report: N
ENDO GIA II 60-4.8 SULU
MDR report key: 1515460
·
Received October 21, 2009
Report
- Report Number
- 2647580-2009-00554
- Event Type
- Injury
- Date Received
- October 21, 2009
- Date of Event
- September 25, 2009
- Report Date
- October 13, 2009
- Manufacturer
- PONCE - USS
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SENT TO FDA ON 10/21/2009.
Description of Event or Problem · 1
PROCEDURE: THORACIC. ACCORDING TO THE REPORTER: AFTER INSERTING THE ENDO GIA 60-4.8 INTO THE THORACIC CAVITY, THE JAW OF THE INSTRUMENT COULD NOT BE OPENED. THIS OCCURRED BEFORE THE DEVICE WAS FIRED OVER TISSUE. SURGERY TIME WAS EXTENDED BEYOND 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA II 60-4.8 SULU | DISPOSABLE STAPLER | GDW | PONCE - USS | P9A0028 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Other |