FDA Adverse Event
Malfunction
Summary report: N
ETHICON ENDO-SURGERY INC
MDR report key: 2025274
·
Received March 15, 2011
Report
- Report Number
- MW5019850
- Event Type
- Malfunction
- Date Received
- March 15, 2011
- Date of Event
- March 11, 2011
- Report Date
- March 15, 2011
- Manufacturer
- ETHICON ENDO SURGERY INC
- Product Code
- LFL
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NJ, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
ACCORDING TO THE EVENT REPORT, THE "HARMONIC FOCUS FELL APART UPON TRYING TO CRANK THE KEY." NOT USED ON PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETHICON ENDO-SURGERY INC | ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH/GRIP | LFL | ETHICON ENDO SURGERY INC | 1349072 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |