FDA Adverse Event
Malfunction
Summary report: N
HS ACE 14 CM SCISSOR HANDLE
MDR report key: 1822210
·
Received December 3, 2007
Report
- Report Number
- 1527736-2007-08192
- Event Type
- Malfunction
- Date Received
- December 3, 2007
- Date of Event
- November 12, 2007
- Report Date
- November 12, 2007
- Manufacturer
- ETHICON ENDO SURGERY, INC. (CINCINNATI)
- Product Code
- LFL
- PMA / PMN Number
- K051036
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN EXPLORATORY PROCEDURE, THE HAND ACTIVATION STOPPED WORKING. THEY CHANGED DEVICES TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HS ACE 14 CM SCISSOR HANDLE | LFL | ETHICON ENDO SURGERY, INC. (CINCINNATI) | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HANDPIECE| GENERATOR |