BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKPULSE-SE LITHOTRIPSY SYSTEM

    MDR report key: 10527857 · Received September 14, 2020

    Report

    Report Number
    3011050570-2020-00074
    Event Type
    Malfunction
    Date Received
    September 14, 2020
    Report Date
    October 6, 2020
    Manufacturer
    GYRUS ACMI INC
    Product Code
    FEO
    PMA / PMN Number
    K142428
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE REVIEW OF THE SERVICE HISTORY RECORDS (SHR). THE DEVICE SERVICE HISTORY RECORDS FOR THIS DEVICE WERE REVIEWED AND ALL RECORDS INDICATED AT THE TIME OF INSPECTION IN DECEMBER 2016, NO ABNORMALITIES CONCERNING THE TRANSDUCER RECEPTACLE WERE NOTED. THE DEVICE WAS REPAIRED AND RETURNED TO SPECIFICATION BY THE ORIGINAL MANUFACTURER. 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 HOUSING. AS STATED ON THE IFU (SPL-IFU REV AM) ,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 RECEIVED AND EVALUATED. EVALUATION DETERMINED THAT THE REPORTED ISSUE WAS CONFIRMED. THE DEVICE CONNECTOR PORT (TRANSDUCER RECEPTACLE) WAS FOUND WITH BROKEN PINS, AND UNABLE TO PLUG IN THE HANDPIECE. A TEST REFERENCE HANDPIECE WAS INSTALLED AND UNIT WORKED, PASSED ALL FUNCTIONAL/ENERGY OUTPUT TEST. THE IDENTIFIED DAMAGED PINS NEED TO BE REPLACED. THE DEVICE WAS PLACED FOR REPAIR. A ROOT CAUSE OF THE REPORTED ISSUE LIKELY ATTRIBUTED TO MISHANDLING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS FOUND WITH A BROKEN CONNECTOR. THE ISSUE OCCURRED DURING AN UNKNOWN PROCEDURE. THERE WERE NO FURTHER DETAILS PROVIDED REGARDING THE EVENT. THERE WAS NO PATIENT IMPACT, OR HARM REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995520 SHOCKPULSE-SE LITHOTRIPSY SYSTEM LITHOTRIPTOR, ULTRASONIC FEO GYRUS ACMI INC SPL-S

    Patients

    Seq Age Sex Outcome Treatment
    1