OLYMPUS HIGH FREQUENCY CABLE

Description of Event or Problem

OLYMPUS RECEIVED A REPORT THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE PT REPORTEDLY EXPERIENCED CARDIOPULMONARY ARREST. THE ANESTHESIOLOGIST AND OTHER HOSPITAL PERSONNEL ATTEMPTED TO RESUSCITATE THE PT, BUT DID NOT SUCCEED AND THE PT EXPIRED. THERE WERE NO ALLEGATIONS OF ANY DEVICE MALFUNCTION WITH THE OLYMPUS EQUIPMENT USED DURING THE PROCEDURE.

Additional Manufacturer Narrative

THE RETURNED EQUIPMENTS WERE TESTED TOGETHER AND ALL OF THE DEVICES WERE FOUND TO OPERATE APPROPRIATELY. ALL OF THE DEVICES PASSED THE ELECTRICAL LEAKAGE TEST, WITH THE EXCEPTION OF THE WA00013A HF CABLE THAT FAILED THE DIELECTRIC STRENGTH TEST. THE A22002A TELESCOPE WAS FOUND TO HAVE A SLIGHT DENT ON THE PROXIMAL END AND DISTAL TIP OF THE TELESCOPE, BUT THE DENTS DID NOT AFFECT ITS FUNCTIONALITY. THE WA00013A HF CABLE WAS FORWARDED TO THE ORIGINAL EQUIPMENT MFR FOR FURTHER EVAL. BASED ON THE PRELIMINARY EVAL RESULTS, IT DOES NOT APPEAR LIKELY THAT THE DEVICES REFERENCED IN THIS REPORT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. HOWEVER, THE CAUSE OF THE PT'S OUTCOME CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL FOLLOW. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.