BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKPULSE-SE LITHOTRIPSY SYSTEM

    MDR report key: 10295186 · Received July 20, 2020

    Report

    Report Number
    3011050570-2020-00021
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Date of Event
    June 23, 2020
    Report Date
    July 20, 2020
    Manufacturer
    GYRUS ACMI INC
    Product Code
    FEO
    PMA / PMN Number
    K142428
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RECEIVED FOR EVALUATION. EVALUATION DETERMINED THAT THE REPORTED ISSUE WAS CONFIRMED. THE DEVICE WAS FOUND TO HAVE A FAULTY TRANSDUCER RECEPTACLE. THE DEVICE WAS PLACED FOR REPAIR. BASED ON EVALUATION FINDINGS, THE REPORTED ISSUE WAS CONFIRMED. THE ISSUE WAS ATTRIBUTED TO A FAULTY TRANSDUCER RECEPTACLE AND NEEDS TO BE REPLACED. THE REPORTED FAILURE IS A KNOWN ISSUE. DAMAGE TO THE RECEPTACLE IS OFTEN INCURRED AS A RESULT OF USE ERROR. THE USER DOES NOT REALIZE THAT ALL CONNECTIONS ARE A PUSH/PULL, INSTEAD THE PLUG IS TWISTED UPON CONNECTION OR REMOVAL. THIS RESULTS IN DAMAGE TO THE PINS INTERNAL TO THE SOCKET AND MAY CRACK OR DAMAGE THE HOUSING. REVIEW OF INSTRUMENT HISTORY REVEALS A PATTERN OF MISHANDLING AS THE UNIT HAS BEEN REPAIRED FOR SIMILAR FAILURES IN 2016 AND 2017. PER IFU (SPL-IFU REV AM) THE USER¿S MANUAL STATES "CONNECT THE TRANSDUCER TO THE GENERATOR BY PRESSING THE PLUG STRAIGHT IN. CAUTION DO NOT TWIST OR TURN THE PLUG." ON PAGE 20, ¿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." IN ADDITION TO INSTRUCTIONS ON CONNECTING THE TRANSDUCER, THE IFU INSTRUCTS THE USER TO INSPECT THE EQUIPMENT PRIOR TO USE ON PAGE 20. "INSPECT THE PLUG PINS, CORD, AND TRANSDUCER BODY FOR MECHANICAL DAMAGE (BENT PINS, CRACKS, ETC.). IF REPAIR IS NECESSARY, PLEASE CONTACT OLYMPUS CUSTOMER SERVICE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SPL-S SHOCKPULSE-SE LITHOTRIPSY SYSTEM EXHIBITED CHECK PROBE ERROR MESSAGE. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. ACCORDING TO THE REPORTER, THEY PUT A SECOND PROBE, WORKED INTERMITTENTLY HOWEVER, THE INTENDED PROCEDURE WAS COMPLETED WITH NO IMPACT OR HARM TO THE PATIENT. THE USER WAS ADVISED TO HAVE THE DEVICE SENT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761021 SHOCKPULSE-SE LITHOTRIPSY SYSTEM LITHOTRIPTOR, ULTRASONIC FEO GYRUS ACMI INC SPL-S

    Patients

    Seq Age Sex Outcome Treatment
    1