FDA Adverse Event
Injury
Summary report: N
ETHICON -J&J- ARTICULATING ENDOSCOPIC LINEAR CUTTER
MDR report key: 2061330
·
Received April 12, 2011
Report
- Report Number
- MW5020270
- Event Type
- Injury
- Date Received
- April 12, 2011
- Date of Event
- March 18, 2011
- Report Date
- April 12, 2011
- Manufacturer
- ETHICON ENDOMECHANICAL SURGICAL
- Product Code
- GDW
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
ACCORDING TO THE SURGEON THE STAPLER MISFIRED AND WOULD NOT UNCLAMP. THE SURGEON HAD TO CUT THE STAPLER OFF THE BOWEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETHICON -J&J- ARTICULATING ENDOSCOPIC LINEAR CUTTER | ECHELON 60 STAPLER | GDW | ETHICON ENDOMECHANICAL SURGICAL | H43774 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Disability |