NONE

Description of Event or Problem

THE FIRST REPORT OF EIGHT FROM THE SAME FACILITY INVOLVING A PENA PROBE. A REPORT WAS RECEIVED FROM A (B)(6) THAT THE PENA PROBE STOPPED/DIDN'T WORK. THE CONSULTANT SURGEON OUT THE CABLE AND EXPOSED THE INNER CABLING WHICH APPEARED TO BE OXIDIZED. THE PROBE WAS IN CONTACT WITH A PATIENT (THE AGE OF THE PATIENT IS NOT AVAILABLE), HOWEVER, THERE WAS NO PATIENT INJURY OR DEATH. THE EVENT LED TO SIGNIFICANT INCREASE IN SURGERY TIME OF 20 MINUTES BECAUSE WHEN THE PROBE FAILED THE STAFF HAD TO EITHER LOCATE ANOTHER WORKING PROBE OR OPEN A NEW ONE. THE PATIENT WAS NOT INJURED AS A RESULT OF THIS DELAY. NO LOT NUMBER WAS AVAILABLE.

Additional Manufacturer Narrative

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.