BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKPULSE LITHOTRIPSY TRANSDUCER.

    MDR report key: 10382018 · Received August 7, 2020

    Report

    Report Number
    3011050570-2020-00033
    Event Type
    Malfunction
    Date Received
    August 7, 2020
    Report Date
    August 27, 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

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT WAS SUBMITTED TO PROVIDE A SUMMARY OF THE INVESTIGATION RESULTS. THE NON-SERVICEABLE DEVICE WAS RETURNED FOR EVALUATION. DURING ROUTINE EVALUATION OF THE RETURNED ASSET, DAMAGE TO THE TRANSDUCER'S CORD WAS NOTED. THE PLUG WAS DAMAGED WHICH PREVENTED PROPER MATING WITH THE RECEPTACLE OF THE GENERATOR UNIT. THE ORIGINAL EQUIPMENT MANUFACTURER (OSTA) PERFORMED A DEVICE HISTORY RECORD REVIEW AND NO ABNORMALITIES WERE NOTED. THIS DEVICE WAS MANUFACTURED (CYBERSONICS INC.) IN JANUARY 2015. AN INVESTIGATION WAS COMPLETED BY THE OEM AND DETERMINED THAT THERE WAS NO MANUFACTURING, MATERIAL OR PROCESSING RELATED CAUSE FOR THIS FAILURE MODE. HOWEVER, THE OBSERVED FAILURE IS A KNOWN PHENOMENON. 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 HOUSING. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE ON PAGE 14 OF THE HE DEVICE IFU (SPL-IFU REV AM) 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." 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."

    Additional Manufacturer Narrative · 1

    THE DEMO/ASSET UNIT WAS RETURNED TO THE SERVICE CENTER FOR A STANDARD EVALUATION. THE UNIT WAS INSPECTED/TESTED AND THE EVALUATION FOUND THE CABLE/CONNECTOR OF THE UNIT WAS DAMAGED AND THE UNIT COULD NOT BE SECURELY CONNECTED TO THE GENERATOR. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AT THIS TIME AS THE INVESTIGATION IS ONGOING. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    THE SERVICE CENTER WAS INFORMED THAT DURING A STANDARD INSPECTION OF THE SHOCKPULSE LITHOTRIPSY TRANSDUCER, THE CONNECTOR FAILED TO SECURELY CONNECT TO THE GENERATOR CONNECTION RECEPTACLE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844953 SHOCKPULSE LITHOTRIPSY TRANSDUCER. LITHOTRIPTOR, ULTRASONIC FEO GYRUS ACMI INC SPL-T

    Patients

    Seq Age Sex Outcome Treatment
    1