FDA Adverse Event
Injury
Summary report: N
ENDO GIA II 45-3.5 DLU
MDR report key: 1030050
·
Received April 15, 2008
Report
- Report Number
- 1219930-2008-00291
- Event Type
- Injury
- Date Received
- April 15, 2008
- Date of Event
- March 17, 2008
- Report Date
- April 9, 2008
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SENT TO FDA ON 04/15/2008.
Description of Event or Problem · 1
PROCEDURE: UNK. ACCORDING TO THE REPORTER: THE SULU DID NOT GIVE A GOOD STAPLE FORMATION, THE ANVIL BENT AWAY FROM THE PUSHERS WHILE FIRING. FOUR DIFFERENT HANDLES AND SIX DIFFERENT LOADING UNITS WERE APPLIED AND THE LAST ONES WORKED. MAXIMUM BLOOD LOSS WAS 100ML. THE SURGEON STAPLED AN EXTRA PIECE OF THE INTESTINE BECAUSE OF THE POOR STAPLE FORMATION. DELAY IN SURGERY TIME WAS OVER 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA II 45-3.5 DLU | SURGICAL STAPLING DEVICE | GDW | NORTH HAVEN - USS | N7J36 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |