FDA Adverse Event
Injury
Summary report: N
ENDO GIA ROTICULATOR 60-3.5 SULU
MDR report key: 2250037
·
Received September 9, 2011
Report
- Report Number
- 1219930-2011-00787
- Event Type
- Injury
- Date Received
- September 9, 2011
- Date of Event
- August 17, 2011
- Report Date
- August 17, 2011
- Manufacturer
- UNITED STATES SURGICAL A
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: UNKNOWN. ACCORDING TO THE REPORTER: THE STAPLE COULD NOT BE FORMED. THE DOCTOR HAD TO USE SUTURE TO FINISH THIS PROCEDURE. PATIENT INVOLVED W/O INJURY. THERE WAS NO FLUID LEAKAGE DUE TO THIS PROBLEM, NOR BLOOD LOSS OF 250CC OR MORE DUE TO THIS PROBLEM, NOR WAS THERE ANY UNANTICIPATED TISSUE LOSS. THE SURGERY TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THIS PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA ROTICULATOR 60-3.5 SULU | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | UNITED STATES SURGICAL A | N0D0134 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |