HF-CABLE, BIPOLAR

Additional Manufacturer Narrative

BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

Description of Event or Problem

IT WAS REPORTED THE MEDICAL DEVICE CONNECTION CABLE'S BIPOLAR LEAD BEGAN TO SPARK DURING A THERAPEUTIC TRANSURETHRAL RESECTION IN SALINE PROCEDURE WHILE THE DEVICE WAS OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. FOLLOWING THE INCIDENT, THE LEAD BROKE. THERE WERE NO REPORTS OF PATIENT HARM.