FDA Adverse Event
Injury
Summary report: N
ETHICON
MDR report key: 1698622
·
Received May 20, 2010
Report
- Report Number
- MW5016050
- Event Type
- Injury
- Date Received
- May 20, 2010
- Date of Event
- May 7, 2010
- Report Date
- May 20, 2010
- Manufacturer
- CQ LABS
- Product Code
- LFL
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING A GASTRIC BANDING LAPAROSCOPIC SURGERY, REPROCESSED HARMONIC ACE SHEARS STOPPED WORKING IN THE MIDDLE OF THE SURGERY. NEW HARMONIC SHEARS WERE OPENED AND USED TO COMPLETE THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETHICON | HARMONIC ACE SHEARS | LFL | CQ LABS | ACE36E | 1008987 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Disability |