FDA Adverse Event
Malfunction
Summary report: N
SELECTOR 35KHZ NEURO HANDPIECE
MDR report key: 2241025
·
Received August 17, 2011
Report
- Report Number
- 8010219-2011-00015
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Report Date
- August 17, 2011
- Manufacturer
- INTEGRA, ANDOVER
- Product Code
- LFL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.
Description of Event or Problem · 1
PRIOR TO INCISION, THE SCRUB TECHNICIAN INSPECTED THE HAND PIECE AND NOTICED THE EXPOSED WIRES AT THE END OF THE HAND PIECE HOUSING. IT WAS STARTING TO PULL AWAY. THERE WAS NO PATIENT CONTACT OR INJURY. ANOTHER HAND PIECE WAS USED INSTEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SELECTOR 35KHZ NEURO HANDPIECE | NA | LFL | INTEGRA, ANDOVER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |