FDA Adverse Event
Malfunction
Summary report: N
CUSA EXCEL 36KHZ STRAIGHT HANDPIECE
MDR report key: 2919851
·
Received January 14, 2013
Report
- Report Number
- 3006697299-2013-00005
- Event Type
- Malfunction
- Date Received
- January 14, 2013
- Date of Event
- December 27, 2012
- Report Date
- January 14, 2013
- Manufacturer
- INTEGRA LIFESCIENCES. LTD
- Product Code
- LBK
- PMA / PMN Number
- K981262
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.
Description of Event or Problem · 1
DURING SURGERY DUE TO CRANIOTOMY FOR TUMOR REMOVAL A (C2602) 36 KHZ HAND PIECE WAS REPORTED TO HAVE BECOME EXCESSIVELY "HOT". THE PROBLEM WITH THE HANDPIECE RESULTED IN NO PT OR USER HARM OR INCIDENT. THE DOCTOR USING IT SIMPLY COMPLAINED IT WAS EXCESSIVELY HOT OR HOTTER THAN NORMAL. EVERYTHING WENT FINE WITH THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 20570 | CUSA EXCEL 36KHZ STRAIGHT HANDPIECE | ULTRASONIC SURGICAL PRODUCTS | LBK | INTEGRA LIFESCIENCES. LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |