FDA Adverse Event
Malfunction
Summary report: N
ETHICON ENDO-SURGERY, INC
MDR report key: 2500947
·
Received March 19, 2012
Report
- Report Number
- MW5024707
- Event Type
- Malfunction
- Date Received
- March 19, 2012
- Date of Event
- March 15, 2012
- Report Date
- March 19, 2012
- Product Code
- LFL
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ASCENT HARMONIC HANDPIECE CAME APART UPON OPENING PACKAGE AT THE HANDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETHICON ENDO-SURGERY, INC | HARMONIC ACE SHEARS WITH ERGONOMIC HANDLE, 5.5 DIA | LFL | ACE 36E | 1026391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |