FDA Adverse Event
Malfunction
Summary report: N
HARMONIC ACE 36 CM
MDR report key: 1003677
·
Received February 14, 2008
Report
- Report Number
- 1527736-2008-00906
- Event Type
- Malfunction
- Date Received
- February 14, 2008
- Date of Event
- January 8, 2008
- Report Date
- January 23, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- LFL
- PMA / PMN Number
- K042777
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAP GASTRIC BYPASS PROCEDURE, THE MAX HAND CONTROL BUTTON STOPPED FUNCTIONING ON THREE DEVICES. THE SURGEON CONTINUED USING THE THIRD DEVICE WITH THE FOOT PEDAL ACTIVATION TO COMPLETE THE CASE. NO PT CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC ACE 36 CM | LFL | ETHICON ENDO-SURGERY, INC. | NA | D4JU05 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR| HANDPIECE |