BEUDAMED
    FDA Adverse Event Death Summary report: N

    OLYMPUS HIGH FREQUENCY CABLE

    MDR report key: 1698587 · Received May 21, 2010

    Report

    Report Number
    9610773-2010-00018
    Event Type
    Death
    Date Received
    May 21, 2010
    Date of Event
    April 22, 2010
    Report Date
    April 22, 2010
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    JOS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS HIGH FREQUENCY CABLE HIGH FREQUENCY CABLE JOS OLYMPUS WINTER & IBE GMBH WA00013A 063

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death OUTER RESECTION SHEATH, MODEL A22023A,LOT 102W-001| HF RESECTION ELECTRODE, MODEL WA22557C, LOT 211209| LIGHT-GUIDE CABLE, MODEL WA03210A| EQUIPMENT INCLUDED:| SAID TO HAVE BEEN IN USE DURING THE PROCEDURE WERE| ALL OF THE FOLLOWING OLYMPUS DEVICES WHICH WERE| INNER RESECTION SHEATH,MODEL A22040A,LOT 086W-0026| ELECTROSURGICAL UNIT, MODEL UES-40, (B) (4)| UES-40 ON BIPOLAR MODE,SETTINGS: CUT-95 & COAG-140| TELESCOPE, MODEL A22002A, LOT 403030| HF RESECTION ELECTRODE, MODEL WA22306D, LOT 212261| WORKING ELEMENT, MODEL WA22367A, LOT 08ZW-0001| RETURNED TO OLYMPUS FOR EVAL. THE OLYMPUS