FDA Adverse Event
Malfunction
Summary report: N
HARMONIC ACE 36 CM
MDR report key: 1190932
·
Received October 9, 2008
Report
- Report Number
- 1527736-2008-03532
- Event Type
- Malfunction
- Date Received
- October 9, 2008
- Date of Event
- April 25, 2008
- Report Date
- April 25, 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
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED IN GOOD CONDITION. NO VISIBLE DAMAGE WAS NOTED. THE HAND-ACTIVATION CONTACTS WERE IN GOOD CONDITION. THE DEVICE WAS TESTED ON A GENERATOR AND ACTIVATED AUTOMATICALLY, IT WAS FOUND THAT THE CONTROL SWITCH ASSEMBLY BUTTONS WERE NOT FUNCTIONAL. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MFG PROCESS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAR PROCEDURE, THE DEVICE KEPT ACTIVATING WITHOUT PUSHING THE HAND-SWITCH AFTER THE SYSTEM CHECK. ANOTHER LIKE DEVICE WAS USED. THERE WAS 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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR| HANDPIECE |