BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKPULSE LITHOTRIPSY TRANSDUCER.

    MDR report key: 10474096 · Received August 31, 2020

    Report

    Report Number
    3011050570-2020-00062
    Event Type
    Malfunction
    Date Received
    August 31, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 DEVICE MET ALL FINAL RELEASE CRITERIA AT THE TIME OF MANUFACTURE. THERE IS NO INDICATION MANUFACTURING PROCESSES CONTRIBUTED TO THE REPORTED EVENT. IT WAS REPORTED THAT DURING AN ASSET RETURN INSPECTION, THE DEVICE WAS TESTED AND OUTPUTS ARE WITHIN STANDARD SPECIFICATIONS HOWEVER, THE DEVICE WAS FOUND WITH A FAULTY CONNECTOR AND UNABLE TO BE LOCKED INTO THE GENERATOR. THE REPORTED FAILURE IS A KNOWN PHENOMENON AND IS PRODUCED AS A RESULT OF DAMAGE TO THE TRANSDUCER PLUG AND/OR RECEPTACLE. DAMAGE TO THE RECEPTACLE IS OFTEN INCURRED AS A RESULT OF USER ERROR, OFTEN THE USER DOES NOT REALIZE ALL CONNECTIONS ARE PUSH/PULL AND INSTEAD THE PLUG IS TWISTED UPON CONNECTION OR REMOVAL. THIS ACTION RESULTS IN DAMAGE TO THE PINS INTERNAL TO THE SOCKET AND MAY CRACK OR DAMAGE THE RECEPTACLE HOUSING. PER THE USER¿S MANUAL, THE TRANSDUCER RECEPTACLE IS ADDRESSED, "CONNECT THE TRANSDUCER TO THE GENERATOR BY PRESSING THE PLUG STRAIGHT IN. CAUTION DO NOT TWIST OR TURN THE PLUG ¿, CONNECT THE TRANSDUCER TO THE GENERATOR BY ALIGNING THE KEY WAY OF THE TRANSDUCER CONNECTOR WITH THE KEY WAY SLOT ON THE TRANSDUCER RECEPTACLE ON THE FRONT PANEL. PUSH STRAIGHT IN. CAUTION DO NOT TWIST OR TURN THE PLUG." OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED AND EVALUATED. AS STATED, THE DEVICE WAS INSPECTED AND OUTPUTS ARE WITHIN STANDARD SPECIFICATIONS HOWEVER, THE DEVICE WAS FOUND WITH A FAULTY CONNECTOR AND UNABLE TO BE LOCKED INTO THE GENERATOR. THE FAULTY CONNECTOR WAS NOTED TO BE A NON-REPAIRABLE ITEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ASSET RETURN INSPECTION, THE DEVICE WAS TESTED AND OUTPUTS ARE WITHIN STANDARD SPECIFICATIONS HOWEVER, THE DEVICE WAS FOUND WITH A FAULTY CONNECTOR AND UNABLE TO BE LOCKED INTO THE GENERATOR. THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORT, NO USER HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936425 SHOCKPULSE LITHOTRIPSY TRANSDUCER. LITHOTRIPTOR, ULTRASONIC FEO GYRUS ACMI INC SPL-T

    Patients

    Seq Age Sex Outcome Treatment
    1