FDA Adverse Event
Malfunction
Summary report: N
HARMONIC ACE 36CM W ERG HANDLE
MDR report key: 1172486
·
Received September 22, 2008
Report
- Report Number
- 3005075853-2008-01859
- Event Type
- Malfunction
- Date Received
- September 22, 2008
- Date of Event
- August 29, 2008
- Report Date
- August 29, 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
- PA, US
- 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 LAP COLECTOMY PROCEDURE, THE DEVICE WAS INTERMITTENTLY GIVING A BEEP WHEN TURNING DOWN THE MAX OR MIN BUTTON. THE DEVICE WOULD SKIP A BEEP, OR SOUND A DOUBLE BEEP, AND THE SURGEON FELT HE NEEDED TO PRESS HARDER ON THE BUTTON. THE CONNECTION ON THE SWITCH BUTTON IS NOT CONSISTENT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC ACE 36CM W ERG HANDLE | LFL | ETHICON ENDO-SURGERY, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR| HANDPIECE |