FDA Adverse Event
Injury
Summary report: N
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
MDR report key: 1023290
·
Received April 1, 2008
Report
- Report Number
- 1219930-2008-00261
- Event Type
- Injury
- Date Received
- April 1, 2008
- Date of Event
- March 5, 2008
- Report Date
- March 11, 2008
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GAG
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
PROCEDURE: LAP SIGMOID COLECTOMY. ACCORDING TO THE REPORTER: A LARGE AMOUNT OF TISSUE WAS CRAMMED INTO THE JAW. THE DEVICE BROKE AND PUNCTURED IMA. THE PATIENT WAS OPENED AND THE SURGEON SUTURED TO STOP BLEEDING. THE BLADE NIPPED THIS TISSUE BUNDLE WHICH INCLUDE A PORTION OF THE IMA PRIOR TO THE STAPLES ENGAGING. PATIENT REPORTED AS FINE. "DEVICE BROKE" WAS STATED AS THE "HANDLE SNAPPING".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA UNIVERSAL 12MM SINGLE USE INST | SURGICAL STAPLING DEVICE | GAG | NORTH HAVEN - USS | N7M253 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention | EXPIRATION DATE: UNK| ENDO GIA ROTICULATOR 45-3.5 SULU| 030455| LOT UNK |