FDA Adverse Event
Malfunction
Summary report: N
HARMONIC ACE 36 CM
MDR report key: 1080426
·
Received July 24, 2008
Report
- Report Number
- 3005075853-2008-00399
- Event Type
- Malfunction
- Date Received
- July 24, 2008
- Date of Event
- May 18, 2008
- Report Date
- June 20, 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
- EC
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 7/11/2008.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE, THE DEVICE STOPPED WORKING. UNKNOWN HOW THE CASE WAS COMPLETED. 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, LLC | NA | D4JR57 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR| HANDPIECE |