BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CW-USLS CYBERWAND USL SYSTEM

    MDR report key: 10308308 · Received July 22, 2020

    Report

    Report Number
    3011050570-2020-00023
    Event Type
    Malfunction
    Date Received
    July 22, 2020
    Report Date
    July 23, 2020
    Manufacturer
    GYRUS ACMI INC
    Product Code
    FFK
    PMA / PMN Number
    K052135
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE CAUSE OF RECEPTACLE DAMAGE CAN LIKELY BE ATTRIBUTED TO USER MISHANDLING. A REVIEW OF INSTRUMENT HISTORY REVEALS THAT THIS ACCOUNT HAS A HISTORY OF SIMILAR DAMAGE. INSTRUMENT HISTORY INDICATES PRIOR SERVICE ON THIS UNIT THEREFORE A SERVICE HISTORY REVIEW WAS COMPLETED IN PLACE OF A DHR REVIEW. THE UNIT WAS SERVICED IN NOVEMBER 2018 BY THE MANUFACTURER, CYBERSONICS INC. THE FOOT SWITCH RECEPTACLE WAS REPLACED AFTER THE CUSTOMER REPORTED THAT THE DEVICE DID NOT FUNCTION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE SERVICE CENTER FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE AND FOUND MINOR SCRATCHES ON THE DEVICE HOUSING. THE FOOTSWITCH WAS EQUIPPED WITH UP TO DATE SOFTWARE. THE CUSTOMER¿S COMPLAINT WAS CONFIRMED AS THE FOOTSWITCH RECEPTACLE WAS FOUND DAMAGED. THE INSTRUCTION MANUAL WARNS USERS ¿IMPROPER CARE AND MAINTENANCE ARE CRITICAL FOR SAFE AND EFFECTIVE OPERATION OF THE CYBERWAND DUAL ULTRASONIC LITHOTRIPSY SYSTEM. WE RECOMMEND CAREFUL INSPECTION OF ALL EQUIPMENT UPON RECEIPT AND PRIOR TO EACH USE AS A SAFEGUARD AGAINST POSSIBLE INJURY TO PATIENT OR OPERATOR. REMOVE THE TRANSDUCER CONNECTOR CAP AND INSPECT THE PLUG PINS, CORD, AND TRANSDUCER BODY FOR MECHANICAL DAMAGE (BENT PINS, CRACKS, ETC.). SHOULD REPAIR BE NECESSARY, CONTACT GYRUS ACMI CUSTOMER SERVICE. CONNECT THE TRANSDUCER TO THE GENERATOR BY ALIGNING THE RED DOTS ON THE TRANSDUCER CONNECTOR WITH THOSE ON THE TRANSDUCER RECEPTACLE ON THE FRONT PANEL. PUSH STRAIGHT IN. CAUTION: DO NOT TWIST OR TURN THE PLUG.

    Description of Event or Problem · 1

    THE SERVICE CENTER WAS INFORMED THAT DURING PREPARATION FOR USE, THE FOOTSWITCH WAS NOTED TO BE BROKEN AND A FAULT ERROR WAS OBSERVED. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772709 CW-USLS CYBERWAND USL SYSTEM LITHOTRIPTOR, ELECTRO-HYDRAULIC FFK GYRUS ACMI INC CW-USLS

    Patients

    Seq Age Sex Outcome Treatment
    1