BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKPULSE LITHOTRIPSY PROBE, REUSABLE,

    MDR report key: 10501620 · Received September 8, 2020

    Report

    Report Number
    3011050570-2020-00067
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Date of Event
    August 10, 2020
    Report Date
    October 20, 2020
    Manufacturer
    GYRUS ACMI INC
    Product Code
    FEO
    PMA / PMN Number
    K142428
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE DEVICE RETURN EVALUATION, COMPLAINT HISTORY REVIEW AND INVESTIGATION CONCLUSION. EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED ISSUE. THE PROBE FRACTURED APPROXIMATELY 6 INCHES FROM THE PROXIMAL END. IN ADDITION, THE SPRING WAS ALSO BROKEN. WHILE A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FAILURE OF THIS SORT IS OFTEN ATTRIBUTED TO USER TECHNIQUE. IT IS IMPORTANT THE PROBE BE HELD CONCENTRIC TO THE INSTRUMENT CHANNEL OF THE ENDOSCOPE. ANY APPLIED TORQUE MAY RESULT IN MISALIGNMENT AND CONTACT WEAR LEADING TO THE FRACTURE OF THE PROBE. AS STATED ON THE INSTRUCTIONS FOR USE AS A PREVENTIVE MEASURE: THE SHOCKPULSE-SE SHOULD BE PLACED IN LIGHT CONTACT WITH THE STONE. IT IS NOT NECESSARY TO PRESS DOWN ON THE STONE WITH A LOT OF PRESSURE. THE PROBE IS FRAGILE. IT IS CRITICAL THAT THE SURGEON DOES NOT BEND OR TORQUE THE PROBES AGAINST THE ENDOSCOPE DURING THE PROCEDURE. THERE IS NO NEED TO ROTATE THE PROBE OR TRANSDUCER; IT WILL NOT IMPROVE FRAGMENTATION OR STONE CLEARANCE. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED AND EVALUATED AT OLYMPUS MALAYSIA SERVICE CENTER SITE. EVALUATION DETERMINED THAT THE DEVICE SHAFT WAS BROKEN. IN ADDITION, THE SPRING WAS FOUND BROKEN AND NON-REPAIRABLE. BOTH OF THE DAMAGES FOUND ON THE DEVICE ARE NON -REPAIRABLE. REPORTED FAILURE WAS CONFIRMED. LIKELY ATTRIBUTED TO USERS MISHANDLING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE PROBE WAS FOUND BROKEN DUE TO HARD AND CALCIFIED STONE. THE ISSUE OCCURRED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE. NO FURTHER DETAILS PROVIDED REGARDING THE REPORTED EVENT. NO PATIENT IMPACT OR HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967195 SHOCKPULSE LITHOTRIPSY PROBE, REUSABLE, LITHOTRIPTOR, ULTRASONIC FEO GYRUS ACMI INC SPL-PR340 D1909043-2

    Patients

    Seq Age Sex Outcome Treatment
    1