FDA Adverse Event
Malfunction
Summary report: N
HARMONIC ACE 36CM W ERG HANDLE
MDR report key: 1162314
·
Received September 8, 2008
Report
- Report Number
- 3005075853-2008-01567
- Event Type
- Malfunction
- Date Received
- September 8, 2008
- Date of Event
- August 5, 2008
- Report Date
- August 18, 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
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A HYSTERECTOMY PROCEDURE, THE SURGEON NOTICED THAT THE TISSUE PAD WAS MISSING. THEY FOUND IT ON THE FLOOR. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITHOUT ANY IMPACT TO THE PT. THE DEVICE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC ACE 36CM W ERG HANDLE | LFL | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HANDPIECE| GENERATOR |