FDA Adverse Event
Malfunction
Summary report: N
HARMONIC ACE 36 CM
MDR report key: 1203762
·
Received October 10, 2008
Report
- Report Number
- 3005075853-2008-02274
- Event Type
- Malfunction
- Date Received
- October 10, 2008
- Date of Event
- September 12, 2008
- Report Date
- September 19, 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
- JA
- 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 AN OVARIAN RESECTION PROCEDURE, THE BLADE WAS BROKEN OFF. IT DID NOT FALL INTO THE PT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.
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 | GENERATOR| HANDPIECE |