FDA Adverse Event
Malfunction
Summary report: N
ULTRACISION** HARMONIC SCALPEL** HAND PIECE
MDR report key: 2946288
·
Received February 6, 2013
Report
- Report Number
- 3005075853-2013-00502
- Event Type
- Malfunction
- Date Received
- February 6, 2013
- Date of Event
- December 1, 2012
- Report Date
- January 22, 2013
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- LFL
- PMA / PMN Number
- K002906
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE HANDPIECE WAS RECEIVED IN GOOD PHYSICAL CONDITION. IT WAS CONNECTED TO A GENERATOR, EVALUATED WITH A TEST INSTRUMENT AND AN ERROR CODE 7 WAS DISPLAYED BY THE SCREEN WHEN TRYING TO PERFORM THE HAND ACTIVATION TEST. THE INSTRUMENT WAS DISASSEMBLED TO PERFORM AN INTERNAL ELECTRICAL TEST THAT REVEALED A SHORT CIRCUIT CONDITION AT THE CABLE LEVEL, AFFECTING THE HAND ACTIVATION FEATURE OF THE DEVICE IN SUCH WAY THAT MADE IT NOT FUNCTIONAL. NO CONCLUSION COULD BE DRAWN AS TO WHAT CAUSED THIS CABLE CONDITION.
Description of Event or Problem · 1
THE HANDPIECE WAS RETURNED WITHOUT INFORMATION AS TO THE ISSUE. NO INFORMATION IS KNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 50814 | ULTRACISION** HARMONIC SCALPEL** HAND PIECE | INSTRUMENT, ULTRASONIC SURGICAL | LFL | ETHICON ENDO-SURGERY, LLC. | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |