FDA Adverse Event
Malfunction
Summary report: N
HARMONIC ACE 36 CM
MDR report key: 1190773
·
Received October 7, 2008
Report
- Report Number
- 3005075853-2008-02143
- Event Type
- Malfunction
- Date Received
- October 7, 2008
- Date of Event
- August 29, 2008
- Report Date
- September 15, 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
- AS
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HAND ACTIVATION FAILED TO WORK. THE DEVICE WAS REMOVED AND REPLACED AND TIGHTENED AGAIN. HOWEVER, IT CONTINUED TO FAIL TO ACTIVATE, WHICH WORKED WELL. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC ACE 36 CM | LFL | ETHICON ENDO-SURGERY, LLC | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR| HANDPIECE |