FDA Adverse Event
Malfunction
Summary report: N
HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDLE AND HAND CONTROL
MDR report key: 1821127
·
Received August 9, 2007
Report
- Report Number
- 1527736-2007-05258
- Event Type
- Malfunction
- Date Received
- August 9, 2007
- Date of Event
- July 26, 2007
- Report Date
- July 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
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A COLECTOMY PROCEDURE THERE WERE TISSUE EFFECT ISSUES WITH THE DEVICE AND THE GENERATOR PRODUCED AN ERROR CODE 5. THE DEVICE STOPPED WORKING ON THE LAST STEP OF THE PROCEDURE SO ANOTHER DEVICE WAS NOT NECESSARY TO COMPLETE THE CASE. THERE WAS NO PT 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 | D4GD2R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR| HANDPIECE |