BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKPULSE LITHOTRIPSY TRANSDUCER.

    MDR report key: 10233493 · Received July 6, 2020

    Report

    Report Number
    3011050570-2020-00015
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Report Date
    August 3, 2020
    Manufacturer
    GYRUS ACMI INC
    Product Code
    FEO
    PMA / PMN Number
    K142428
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED (AT OEKG GERMANY) FOR EVALUATION. THE EVALUATION OF THE DEVICE NOTED THE TRANSDUCER WAS DEFECTIVE AS NO ACTIVATION COULD BE DETECTED. THE EVALUATION DETERMINED THE LIKELY CAUSE OF THE DAMAGE OF THE DEVICE WAS THE RESULT OF WRONG USAGE (OR HANDLING) OF THE DEVICE. THE DEVICE WILL NOT BE RETURNED FOR FURTHER INVESTIGATION OF THE REPORTED "DISPLAYS ERROR AND CHECK PROBE" A REVIEW OF THE DEVICE HISTORY RECORDS SUGGESTS THE UNIT MET ALL FINAL RELEASE CRITERIA AND PASSED ALL VISUAL, ELECTRICAL AND FUNCTIONAL TESTING PRIOR TO SHIPMENT. AN INVESTIGATION WAS COMPLETED; THERE WAS NO MANUFACTURING, MATERIAL OR PROCESSING RELATED CAUSE FOR THIS FAILURE MODE. BASED ON THE EVALUATION OF THE DEVICE, THE ROOT CAUSE HAS BEEN DETERMINED TO BE ATTRIBUTED TO "WRONG USAGE (OR HANDLING) OF THE DEVICE". OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED (AT (B)(6) FOR EVALUATION. THE PRELIMINARY EVALUATION OF THE DEVICE NOTED THE TRANSDUCER WAS DEFECTIVE AS NO ACTIVATION COULD BE DETECTED. THE DEVICE IS NON-SERVICEABLE AND IS EXPECTED TO BE RETURNED TO THE MANUFACTURER FOR FURTHER INVESTIGATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS INFORMED THAT DURING INITIAL SET-UP, THE SHOCKPULSE LITHOTRIPSY TRANSDUCER WAS NOT WORKING AS IT DISPLAYED AN ERROR AND TO CHECK THE PROBE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695811 SHOCKPULSE LITHOTRIPSY TRANSDUCER. LITHOTRIPTOR, ULTRASONIC FEO GYRUS ACMI INC SPL-T

    Patients

    Seq Age Sex Outcome Treatment
    1