FDA Adverse Event
Malfunction
Summary report: N
HARMONIC ACE 36CM W ERG HANDLE
MDR report key: 1211893
·
Received October 23, 2008
Report
- Report Number
- 3005075853-2008-02532
- Event Type
- Malfunction
- Date Received
- October 23, 2008
- Date of Event
- September 30, 2008
- Report Date
- September 30, 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
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 10/23/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN LAVH PROCEDURE, THE TISSUE PAD BECAME BURNED. NO PIECE FELL INTO THE PT. ANOTHER DEVICE WAS USED WITH A NEW TROCAR TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC ACE 36CM W ERG HANDLE | LFL | ETHICON ENDO-SURGERY, LLC. | NA | E4LT7A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HANDPIECE| GENERATOR |