FDA Adverse Event
Malfunction
Summary report: N
SELECTOR CONSOLE 120V WITH FOOTSWITCH
MDR report key: 2122092
·
Received May 24, 2011
Report
- Report Number
- 8010219-2011-00006
- Event Type
- Malfunction
- Date Received
- May 24, 2011
- Date of Event
- April 7, 2011
- Report Date
- May 24, 2011
- Manufacturer
- INTEGRA, ANDOVER
- Product Code
- LFL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.
Description of Event or Problem · 1
THE SELECTOR CONSOLE DID NOT RECOGNIZE ANY HANDPIECES THAT WAS ATTACHED TO IT. THE HANDPIECES WORKED FINE WITH ALL OTHER CONSOLES. THE PRODUCT PROBLEM WAS DISCOVERED PRIOR TO THE CRANIAL SURGERY AND BEFORE THE ANESTHETIST DID ANYTHING TO THE PT. IT WAS REPORTED THAT THERE WAS A FIVE HOUR DELAY IN SURGERY. THE SURGICAL CASE WAS PUT ON HOLD UNTIL A REPLACEMENT CONSOLE FROM A DISTRIBUTOR ARRIVED AT THE HOSPITAL. THE PT OUTCOME WAS REPORTED AS "OK."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SELECTOR CONSOLE 120V WITH FOOTSWITCH | NA | LFL | INTEGRA, ANDOVER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |