FDA Adverse Event
Malfunction
Summary report: N
HARMONIC ACE 23 CM
MDR report key: 1121922
·
Received August 13, 2008
Report
- Report Number
- 3005075853-2008-01176
- Event Type
- Malfunction
- Date Received
- August 13, 2008
- Date of Event
- July 21, 2008
- Report Date
- July 31, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- LFL
- PMA / PMN Number
- K042777
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 08/13/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A THYROIDECTOMY PROCEDURE, THE SCRUB NURSE WASHED THE JAW OF THE DEVICE WITH GAUZE AS USUAL. BUT THE TISSUE PAD BECAME SEPARATED FROM THE JAW. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC ACE 23 CM | LFL | ETHICON ENDO-SURGERY, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HANDPIECE| GENERATOR |