BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CW-USLTA CYBERWAND ADVANCED TRANSDUCER

    MDR report key: 10111682 · Received June 2, 2020

    Report

    Report Number
    3005975494-2020-00009
    Event Type
    Malfunction
    Date Received
    June 2, 2020
    Report Date
    June 24, 2020
    Manufacturer
    GYRUS ACMI INC
    Product Code
    FFK
    PMA / PMN Number
    K120303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ADDITIONAL INFORMATION: H6, H10 DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. THE NON-CONFORMANCES ARE LIKELY ATTRIBUTABLE TO GENERAL WEAR AND TEAR AS THE UNIT HAS BEEN IN SERVICE SINCE LATE 2014. DURING THIS TIME PERIOD IT IS POSSIBLE THE DEVICE HAS OUTLIVED ITS VALIDATED LIFE SPAN. PER THE DEVICE IFU, (80862 REV AG, PAGE 17) "CAUTION: THE CYBERWAND TRANSDUCER HAS A VALIDATED LIFETIME OF 100 REUSES. FOLLOW HOSPITAL PROCEDURE FOR TRACKING NUMBER OF USES." FURTHERMORE, CLEANING METHODS MAY HAVE CONTRIBUTED TO DEGRADATION OF THE DEVICE, "CAUTION: THE CYBERWAND TRANSDUCER HAS NOT BEEN VALIDATED IN AUTOMATED WASHING-DISINFECTION EQUIPMENT. THE MANUAL CLEANING STEPS AS DEFINED IN THIS SECTION MUST BE FOLLOWED." OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE THROUGH REGULAR TRENDING ACTIVITIES AS DEFINED BY OLYMPUS SURGICAL TECHNOLOGIES AMERICA QUALITY MANAGEMENT SYSTEM PROCEDURE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND THE WIRE TO THE HAND PIECE BODY WAS FOUND TO BE TORN. THIS HAS BEEN DETERMINED TO BE A REPORTABLE MALFUNCTION. THE CAUSE CANNOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER WITHOUT A REPORTED COMPLAINT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572453 CW-USLTA CYBERWAND ADVANCED TRANSDUCER LITHOTRIPTOR, ELECTRO-HYDRAULIC FFK GYRUS ACMI INC CW-USLTA

    Patients

    Seq Age Sex Outcome Treatment
    1