FDA Adverse Event
Malfunction
Summary report: N
HARMONIC ACE 36CM W ERG HANDLE
MDR report key: 1121883
·
Received August 13, 2008
Report
- Report Number
- 3005075853-2008-01141
- Event Type
- Malfunction
- Date Received
- August 13, 2008
- Date of Event
- July 28, 2008
- Report Date
- July 29, 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
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 08/13/2008.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TISSUE PAD FELL OFF INTO THE PT. A SECOND DEVICE WAS OPENED AND THE SAME THING OCCURRED. THE PADS WERE REMOVED. A THIRD DEVICE WAS USED 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 | E4L41K |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR| HANDPIECE |