BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKPULSE LITHOTRIPSY TRANSDUCER.

    MDR report key: 10422357 · Received August 18, 2020

    Report

    Report Number
    3011050570-2020-00045
    Event Type
    Malfunction
    Date Received
    August 18, 2020
    Report Date
    January 18, 2021
    Manufacturer
    GYRUS ACMI INC
    Product Code
    FEO
    PMA / PMN Number
    K142428
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    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), UNIQUE DEVICE IDENTIFIER (UDI) NUMBER AND INVESTIGATION CONCLUSION. DEVICE EVALUATION CONFIRMED THE REPORTED ISSUE AS THE TRANSDUCER WAS NOT PRODUCING ANY OUTPUT AND BOTH THE CHECK PROBE BOX AND ERROR BOX ILLUMINATED RED INDICATING THE TRANSDUCER WAS NOT WORKING PROPERLY. THERE WAS NO PHYSICAL DAMAGE NOTED DURING DEVICE INSPECTION. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED THE PRODUCT MET ALL SPECIFICATIONS UPON RELEASE. THE DEVICE WAS NOT OPENED UP AS THE USER HAS REQUESTED THE DEVICE BACK ALTHOUGH IT IS NOT A SERVICEABLE PRODUCT. THE DEVICE IS FULLY TESTED FOR FUNCTION AFTER THE MANUFACTURING PROCESS, WHICH MEANS IT WAS FULLY FUNCTIONAL AT THIS TIME. HOWEVER WITH THE CAUSES SPECIFIED THE DEVICE NEEDS TO BE STERILIZED BY THE USER, WHICH COULD HAVE CAUSED WATER INGRESS OR A WIRE SOLDER DISCONNECT DURING THE ULTRASONIC VIBRATION. THEREFORE, LIKELY CAUSES OF THE REPORTED FAILURE ARE FLUID INGRESS OR AN INTERNAL ISSUE WITH THE BLUE AND BROWN WIRE. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO THE SERVICE CENTER FOR EVALUATION; HOWEVER, THE DEVICE EVALUATION IS STILL PENDING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR USE, THE DEVICE EXHIBITED AN ERROR DURING ACTIVATION EVEN AFTER CHANGING THE PROBES. ACCORDING TO THE REPORTER, PER THE LEGAL MANUFACTURER USER¿S MANUAL THE SERVICE LIFE OF THE DEVICE ARE 100 HOURS OF USE, HOWEVER, THE DEVICE PER THE REPORTER ONLY HAS ABOUT 50 HOURS OF USE AND AN ISSUE OCCURRED. THE SITE SERVICE FIELD TECHNICIAN CONFIRMED THAT THERE IS NO VISIBLE MECHANICAL DAMAGE TO THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886274 SHOCKPULSE LITHOTRIPSY TRANSDUCER. LITHOTRIPTOR, ULTRASONIC FEO GYRUS ACMI INC SPL-T

    Patients

    Seq Age Sex Outcome Treatment
    1