FDA Adverse Event
Injury
Summary report: N
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
MDR report key: 1522799
·
Received November 4, 2009
Report
- Report Number
- 1219930-2009-00750
- Event Type
- Injury
- Date Received
- November 4, 2009
- Date of Event
- September 30, 2009
- Report Date
- November 2, 2009
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SENT TO FDA ON 11/04/2009.
Description of Event or Problem · 1
PROCEDURE: RESECTION. ACCORDING TO THE REPORTER: STAPLES DID NOT FORM PROPERLY. BLOOD LOSS WAS LESS THAN 250CC. THE PROCEDURE WAS CONVERTED FROM ENDOSCOPIC TO OPEN SURGERY AND THE PROCEDURE TIME WAS EXTENDED BEYOND 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA UNIVERSAL 12MM SINGLE USE INST | DISPOSABLE STAPLER | GDW | NORTH HAVEN - USS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | 030423| ENDO GIA II 45-4.8 SULU |