FDA Adverse Event
Malfunction
Summary report: N
HARMONIC ACE 36 CM
MDR report key: 1182565
·
Received October 3, 2008
Report
- Report Number
- 1527736-2008-03665
- Event Type
- Malfunction
- Date Received
- October 3, 2008
- Date of Event
- May 15, 2008
- Report Date
- May 19, 2008
- Manufacturer
- ETHICON ENDO SURGERY, INC. (CINCINNATI)
- Product Code
- LFL
- PMA / PMN Number
- K042777
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 06/11/2008. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED WITH THE BLADE SCRATCHED; THE BLADE WAS RECEIVED COMPLETE AND NOT BROKEN. THE DEVICE WAS TESTED WITH A GENERATOR AND WAS FUNCTIONAL. THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAP SURPRACERVICAL HYSTERECTOMY PROCEDURE, THE TIP BROKE OFF. THE TIP WAS RECOVERED. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE WITH NO PT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC ACE 36 CM | NONE | LFL | ETHICON ENDO SURGERY, INC. (CINCINNATI) | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR| HANDPIECE |