BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKPULSE-SE LITHOTRIPSY SYSTEM (REUSAB

    MDR report key: 10398808 · Received August 12, 2020

    Report

    Report Number
    3011050570-2020-00039
    Event Type
    Malfunction
    Date Received
    August 12, 2020
    Report Date
    September 2, 2020
    Manufacturer
    GYRUS ACMI INC
    Product Code
    FEO
    PMA / PMN Number
    K142428
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE DEVICE RETURN EVALUATION, REVIEW OF THE DEVICE HISTORY RECORDS (DHR), REVIEW OF DHR RECORDS INDICATES THE UNIT MET ALL FINAL RELEASE CRITERIA PRIOR TO RELEASE. THIS INCLUDES PASSING EXTENSIVE VISUAL INSPECTION AND FUNCTIONAL AND ELECTRICAL SAFETY TESTING AT THE TIME OF MANUFACTURER. THIS SUGGESTS MANUFACTURING DID NOT CONTRIBUTE TO THE REPORTED FAILURE. IT WAS REPORTED THAT THE DEVICE TRANSDUCERS WERE NOT RECOGNIZED. EVALUATION OF THE RETURNED DEVICE CONFIRMED THE COMPLAINT. THE FAILURE WAS ATTRIBUTED TO A DAMAGED TRANSDUCER RECEPTACLE WHICH WAS OBSERVED TO BE "BURNT". AS STATED IN THE DEVICE IFU (INSTRUCTION FOR USE) IT INSTRUCTS THE USER TO INSPECT THE EQUIPMENT FOR DAMAGE PRIOR TO USE. "MAKE SURE THAT THE FOLLOWING SHOCKPULSE-SE SYSTEM EQUIPMENT IS PRESENT FOR THE PROCEDURE. THE OPERATOR SHOULD ENSURE THAT THE GENERATOR AND ALL CABLES AND ALL COMPONENTS ON TRANSDUCER ARE UNDAMAGED PRIOR TO BEGINNING ANY PROCEDURE." OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVALUATION. EVALUATION DETERMINED THAT THE DEVICE WAS FOUND WITH DAMAGED WITH A BURNT TRANSDUCER RECEPTACLE. THE TRANSDUCER WAS CONNECTED AND ACTIVATED IMMEDIATELY WITHOUT PRESSING ANY ACTIVATION BUTTON. THE OUTPUT POWER WAS FOUND LOW HOWEVER, IT WAS AUDIBLE, AND DEVICE WAS FOUND SWITCHED TO ERROR MODE. THE TRANSDUCER PLUG NEEDS TO BE REPLACED. THE DEVICE WAS PLACED FOR REPAIR. BASED ON THE EVALUATION FINDINGS, THE REPORTED ISSUE WAS CONFIRMED. THE REPORTED FAILURE WAS DUE TO DAMAGED, BURNT TRANSDUCER ATTRIBUTED TO COMPONENT FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE TRANSDUCERS WERE NOT RECOGNIZED. NO FURTHER DETAILS WERE PROVIDED REGARDING THE EVENT. THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862620 SHOCKPULSE-SE LITHOTRIPSY SYSTEM (REUSAB LITHOTRIPTOR, ULTRASONIC FEO GYRUS ACMI INC SPL-SR

    Patients

    Seq Age Sex Outcome Treatment
    1