FDA Adverse Event
Malfunction
Summary report: N
HARMONIC ACE 36 CM
MDR report key: 1003664
·
Received February 14, 2008
Report
- Report Number
- 1527736-2008-00915
- Event Type
- Malfunction
- Date Received
- February 14, 2008
- Date of Event
- January 22, 2008
- Report Date
- January 23, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- LFL
- PMA / PMN Number
- K042777
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PROSTATECTOMY PROCEDURE THAT THE MAX HAND CONTROL BUTTON DOES NOT WORK. ANOTHER LIKE DEVICE WAS USED. THERE WAS NO PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC ACE 36 CM | LFL | ETHICON ENDO-SURGERY, INC. | NA | D4JA5K |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR| HANDPIECE |