PK FRONT LOAD,IGLESIAS,WORKING ELEMENT

Additional Manufacturer Narrative

A REVIEW OF DHR WAS CONDUCTED FOR THE SUBJECT DEVICE. THE DEVICE WAS MANUFACTURED IN APRIL 2010. THERE WERE NO DEVIATIONS, NONCONFORMING ISSUES OR ANY CORRECTIVE ACTION ISSUE DURING THE MANUFACTURING PROCESS.

Additional Manufacturer Narrative

THE CUSTOMER RETURNED THE WORKING ELEMENT AND THE SUPERLOOP ELECTRODE WITH NO HF CABLE. A VISUAL INSPECTION OF THE WORKING ELEMENT WAS PERFORMED; NON-OLYMPUS MARKINGS ENGRAVED ON THE WORKING ELEMENT, CONSISTENT THAT THE DEVICE MAY HAVE BEEN REPAIRED BY AN UNAUTHORIZED THIRD PARTY. THE WORKING ELEMENT BLOCK ACTUATOR WAS BURNED AND CHARRED. IN ADDITION, THE CONNECTOR SIDE OF THE ELECTRODE AND HF CABLE ARE BURNED AND DAMAGED. CHARRING WAS ALSO OBSERVED ON THE ELECTRODES PROXIMAL ENDS. A WATER LEAK TEST WAS PERFORMED ON THE WORKING ELEMENT AND IT FAILED THE LEAK TEST BETWEEN SEAL AND HANDLE. THE MOST LIKELY CAUSE OF THE REPORTED COMPLAINT IS DUE TO A BAD SEAL WITHIN THE HANDLE OF THE WORKING ELEMENT. WHICH CAN CAUSE WATER LEAK THROUGH THE HANDLE ONTO THE BLOCK ACTUATOR AND CAN LEAD TO ELECTRICAL SHORTING.

Description of Event or Problem

OLYMPUS WAS INFORMED THAT AT THE BEGINNING OF A TRANSURETHRAL RESECTION OF A BLADDER TUMOR, THE DOCTOR PRESSED THE PEDAL TO CUT AND THE DEVICE SPARKED AT THE AREA WHERE THE LOOP ELECTRODE, AND ITS CABLE ARE CONNECTED. SMOKE WAS MINIMAL SO NO EVACUATION OF THE OPERATING ROOM WAS NEEDED. THE INTENDED PROCEDURE WAS COMPLETED WITH A BUTTON ELECTRODE. THERE WAS NO PATIENT OR USER INJURY REPORTED. THE SUPER LOOP ELECTRODE AND CONNECTIONS WERE INSPECTED; NO ANOMALIES WERE OBSERVED. THERE WERE NO ERRORS DISPLAYED ON THE GENERATOR.