BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKPULSE LITHOTRIPSY PROBE, REUSABLE,

    MDR report key: 10521076 · Received September 11, 2020

    Report

    Report Number
    3011050570-2020-00072
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Date of Event
    August 16, 2020
    Report Date
    October 26, 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 REVIEW OF THE DEVICE HISTORY RECORDS (DHR). THE DEVICE HISTORY RECORDS FOR THIS DEVICE WERE REVIEWED AND ALL RECORDS INDICATED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MET FINAL PRODUCT RELEASE CRITERIA. NO ABNORMALITIES WERE FOUND. 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 IFU AND AS A PREVENTIVE MEASURE, THE USER MANUAL STATES: 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 (B)(4). EVALUATION DETERMINED THAT THE REPORTED ISSUE WAS CONFIRMED. THE UNIT PROBE WAS FOUND FRACTURED NEAR THE BRAZE JOINT AT THE PROXIMAL END OF THE DEVICE. DAMAGES FOUND ON THE DEVICE ARE NON -REPAIRABLE. REPORTED FAILURE LIKELY ATTRIBUTED TO USER HANDLING ISSUE.

    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 THERAPEUTIC 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
    988462 SHOCKPULSE LITHOTRIPSY PROBE, REUSABLE, LITHOTRIPTOR, ULTRASONIC FEO GYRUS ACMI INC SPL-PR340 D1807526

    Patients

    Seq Age Sex Outcome Treatment
    1