HF-CABLE, BIPOLAR

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: AGE-RELATED WEAR IN CONNECTION WITH REPEATED EXTREME BENDING OR TENSILE LOADS LED TO THE BREAKAGE THE WIRES IN THE CABLE. THIS CAN CAUSE A VOLTAGE SPIKE AT THE DAMAGED AREA WHEN THE GENERATOR IS ACTIVATED, RESULTING IN A SPARK AND EVEN COMPLETE DETACHMENT OF THE CONNECTOR. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

IT WAS REPORTED THE MEDICAL DEVICE CONNECTION CABLE OVERHEATED AND WAS CUT. THE ISSUE WAS FOUND DURING A THERAPEUTIC ENDOSCOPIC PROSTATE RESECTION PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.