FDA Adverse Event
Malfunction
Summary report: N
HARMONIC ACE
MDR report key: 3032096
·
Received March 29, 2013
Report
- Report Number
- 3032096
- Event Type
- Malfunction
- Date Received
- March 29, 2013
- Date of Event
- December 15, 2011
- Report Date
- February 20, 2013
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- LFL
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AZ, US
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 129790 | HARMONIC ACE | INSTRUMENT, ULTRASONIC, SURGICAL | LFL | ETHICON ENDO-SURGERY, LLC | * | H91M1C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR |