FDA Adverse Event
Injury
Summary report: N
ENDO GIA ROTICULATOR 60-3.5 SULU
MDR report key: 2221518
·
Received August 17, 2011
Report
- Report Number
- 1219930-2011-00694
- Event Type
- Injury
- Date Received
- August 17, 2011
- Date of Event
- August 11, 2011
- Report Date
- August 12, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: GASTRECTOMY. ACCORDING TO THE REPORTER: AFTER THE 2ND FIRING, THE KNIFE WOULD NOT RETURN. ADD'L RESECTION OF TISSUE WAS NEEDED TO REMOVE THE DEVICE. THE YELLOW TAB MIGHT HAVE BEEN REMOVED BEFORE LOADING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA ROTICULATOR 60-3.5 SULU | DISPOSABLE STAPLER | GDW | UNITED STATES SURGICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability | ENDO GIA UNIVERSAL 12MM SINGLE USE INST| CATALOG# 030449 |