FDA Adverse Event
Malfunction
Summary report: N
HARMONIC FOCUS
MDR report key: 2941016
·
Received January 24, 2013
Report
- Report Number
- 2941016
- Event Type
- Malfunction
- Date Received
- January 24, 2013
- Date of Event
- January 17, 2013
- Report Date
- January 24, 2013
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- LFL
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
SURGEON WAS USING THE HARMONIC SCALPEL. HE REPORTED THAT THE INSTRUMENT WAS NOT CUTTING WELL - NOT AS WELL AS IT SHOULD AND NOT AS WELL AS USUAL.OR TEAM OFFERED TO REPLACE THE DISPOSABLE HANDPIECE BUT HE SAID HE WAS FINE CONTINUING TO USE THE MALFUNCTIONING HANDPIECE.THE CORD AND MACHINE WERE LATER TESTED AND WERE FOUND TO BE FINE, SO IT WAS DETERMINED IT WAS THE HANDPIECE THAT WAS NOT WORKING PROPERLY.THE SURGEON HAD NO TROUBLE FINISHING THE PROCEDURE AND THERE WAS NO NEGATIVE EFFECT TO THE PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?HEMORROIDECTOMY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 34622 | HARMONIC FOCUS | INSTRUMENT, ULTRASONIC SURGICAL | LFL | ETHICON ENDO-SURGERY, INC. | * | J4AH2G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | NO OTHER THERAPIES| UNKNOWN BUT PROBABLY NOT APPLICABLE |