FDA Adverse Event
Malfunction
Summary report: N
HARMONIC ACE 36 CM
MDR report key: 1823694
·
Received November 16, 2007
Report
- Report Number
- 1527736-2007-07798
- Event Type
- Malfunction
- Date Received
- November 16, 2007
- Date of Event
- October 15, 2007
- Report Date
- October 31, 2007
- 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
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THERE WAS A BROKEN BLADE. THE GENERATOR WORKED INTERMITTENTLY. THE ACTIVE BLADE BROKE AND FELL OUTSIDE THE PT. COMPLETED WITH THE SAME LIKE PRODUCT. THERE WAS NO PT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC ACE 36 CM | LFL | ETHICON ENDO SURGERY, INC. (CINCINNATI) | NA | D4HJ58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HANDPIECE| GENERATOR |