FDA Adverse Event
Injury
Summary report: N
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
MDR report key: 2221572
·
Received August 18, 2011
Report
- Report Number
- 1219930-2011-00704
- Event Type
- Injury
- Date Received
- August 18, 2011
- Date of Event
- July 1, 2011
- Report Date
- August 2, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: SIGMOIDECTOMY. ACCORDING TO THE REPORTER: THE FIRST INSTRUMENT BROKE THE STAPLE LINE WAS DEFECTIVE; A SECOND INSTRUMENT WAS USED, AND THE SAME PROBLEM OCCURRED. FOUR UNITS GAVE THE SAME RESULTS. THE PROCEDURE WAS CONVERTED TO AN OPEN SURGERY AND UTILIZATION OF A 50MM LINEAR INSTRUMENT WAS DONE TO COMPLETE THE OPERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA UNIVERSAL 12MM SINGLE USE INST | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | UNITED STATES SURGICAL | N9J0322 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |