BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKPULSE-SE LITHOTRIPSY SYSTEM

    MDR report key: 10561162 · Received September 21, 2020

    Report

    Report Number
    3011050570-2020-00083
    Event Type
    Malfunction
    Date Received
    September 21, 2020
    Date of Event
    August 27, 2020
    Report Date
    November 6, 2020
    Manufacturer
    GYRUS ACMI INC
    Product Code
    FEO
    PMA / PMN Number
    K142428
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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. THE DEVICE WAS NOT RETURNED FOR EVALUATION. TROUBLESHOOTING IDENTIFIED THE FOOTSWITCH AS THE CAUSE OF THE ERROR MESSAGE. IT WAS RECOMMENDED EITHER THE CUSTOMER PURCHASE A NEW FOOTSWITCH OR SEND THE UNIT IN FOR EVALUATION. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. THE CAUSE OF THE ISSUE CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THERAPEUTIC PROCEDURE THE DEVICE ¿PROBE CHECK¿, AND ¿ERROR INDICATOR¿ TURNED RED WHEN THE USER STEPPED ON THE FOOTSWITCH AFTER 3 SECONDS. THE USER TRIED TWO TRANSDUCER, AND RECEIVED THE SAME ISSUE. THE SERIAL NUMBERS FOR THE TWO TRANSDUCER WERE NOT PROVIDED. THE PROCEDURE TOOK LONGER THAN EXPECTED, HOWEVER, WAS ABLE TO BE COMPLETED. THERE WAS NO PATIENT HARM OR INJURY REPORTED. NO USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028245 SHOCKPULSE-SE LITHOTRIPSY SYSTEM LITHOTRIPTOR, ULTRASONIC FEO GYRUS ACMI INC SPL-S

    Patients

    Seq Age Sex Outcome Treatment
    1