FDA Adverse Event
Malfunction
Summary report: N
HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDLE AND HAND CONTROL
MDR report key: 1831695
·
Received September 12, 2007
Report
- Report Number
- 1527736-2007-06025
- Event Type
- Malfunction
- Date Received
- September 12, 2007
- Date of Event
- August 29, 2007
- Report Date
- August 30, 2007
- Manufacturer
- ETHICON ENDO SURGERY, INC (CINCINNATI)
- Product Code
- LFL
- PMA / PMN Number
- K062000
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN OPEN COLECTOMY PROCEDURE, THE MINIMUM ACTIVATION BUTTON STOPPED WORKING. ANOTHER DEVICE WAS NOT NECESSARY AS THE PROCEDURE WAS ALMOST COMPLETE. THERE WAS NO PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDLE AND HAND CONTROL | LFL | ETHICON ENDO SURGERY, INC (CINCINNATI) | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HANDPIECE| GENERATOR |