FDA Adverse Event
Malfunction
Summary report: N
ULTRACISION HARMONIC SCALPEL HAND PIECE
MDR report key: 726416
·
Received June 13, 2006
Report
- Report Number
- 1527736-2006-02697
- Event Type
- Malfunction
- Date Received
- June 13, 2006
- Date of Event
- April 19, 2006
- Report Date
- April 24, 2006
- Manufacturer
- ETHICON ENDO SURGERY, INC.(CINCINNATI)
- Product Code
- LFL
- PMA / PMN Number
- k002906
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION: THE HAND PIECE WAS RETURNED WITH A LOOSE MOUNT. THE ANALYSIS WAS PERFORMED AND WAS FOUND THAT THE HAND PIECE NO LONGER MEETS THE SPECIFICATIONS FOR CONTINUITY. IT WAS TESTED ON A GENERATOR AND NO ERROR CODES WERE FOUND. THE HAND PIECE WAS DISASSEMBLED, A TORN ACOUSTIC ISOLATOR AND EVIDENCE OF MOISTURE INGRESS WERE FOUND IN THE INSTRUMENT. 510(K) NUMBER IS K002906.
Description of Event or Problem · 1
THE CUSTOMER RECEIVED ERROR 5 DURING A CASE AND USED A 2ND HANDPIECE TO SOLVE THE PROBLEM. THERE WAS NO PT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRACISION HARMONIC SCALPEL HAND PIECE | LFL | LFL | ETHICON ENDO SURGERY, INC.(CINCINNATI) | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | 1.GENERATOR, 2.ULTRASONIC SHEARS. |