FDA Adverse Event
Malfunction
Summary report: N
ETHICON ENDO SURGERY LLC
MDR report key: 2440416
·
Received January 31, 2012
Report
- Report Number
- MW5024108
- Event Type
- Malfunction
- Date Received
- January 31, 2012
- Date of Event
- January 10, 2012
- Report Date
- January 31, 2012
- Manufacturer
- ETHICON ENDO SURGERY
- Product Code
- LFL
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING LAPAROSCOPIC CASE, REFURBISHED HARMONIC ACE FAILED TO WORK PROPERLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETHICON ENDO SURGERY LLC | HARMONIC ACE | LFL | ETHICON ENDO SURGERY | 1719749 - STYKER/AS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR |