FDA Adverse Event
Malfunction
Summary report: N
HARMONIC ACE 36 CM
MDR report key: 1181649
·
Received September 30, 2008
Report
- Report Number
- 3005075853-2008-01983
- Event Type
- Malfunction
- Date Received
- September 30, 2008
- Date of Event
- August 21, 2008
- Report Date
- September 5, 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
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAP VENTRAL HERNIA CASE, THE TISSUE PAD FELL OFF INTO THE PATIENT, BUT WAS ABLE TO BE RETRIEVED WITH GRASPERS. ANOTHER DEVICE WAS NOT NEEDED TO COMPLETE THE CASE SINCE THIS OCCURRED AT THE END OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC ACE 36 CM | LFL | ETHICON ENDO-SURGERY, LLC | NA | E4L99L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR| HANDPIECE |