FDA Adverse Event
Malfunction
Summary report: N
HARMONIC ACE 36 CM
MDR report key: 1082916
·
Received July 25, 2008
Report
- Report Number
- 3005075853-2008-00694
- Event Type
- Malfunction
- Date Received
- July 25, 2008
- Date of Event
- June 26, 2008
- Report Date
- July 2, 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
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
D4; H4, 6: INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE ACTIVE BLADE BROKE OFF AND DROPPED ON THE FLOOR. THERE WERE NO PATIENT ADVERSE CONSEQUENCES. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC ACE 36 CM | LFL | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HANDPIECE| GENERATOR |