BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTH NET RETRIEVER

    MDR report key: 9779982 · Received March 2, 2020

    Report

    Report Number
    MW5093484
    Event Type
    Malfunction
    Date Received
    March 2, 2020
    Date of Event
    February 25, 2020
    Report Date
    February 28, 2020
    Manufacturer
    US ENDOSCOPY GROUP, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ROTH NET WOULD NOT OPEN. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241099 ROTH NET RETRIEVER LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ US ENDOSCOPY GROUP, INC. 1915049

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR