BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTHNET RETRIEVER

    MDR report key: 9769602 · Received February 27, 2020

    Report

    Report Number
    MW5093352
    Event Type
    Malfunction
    Date Received
    February 27, 2020
    Date of Event
    February 22, 2020
    Report Date
    February 25, 2020
    Manufacturer
    US ENDOSCOPY GROUP, INC.
    Product Code
    FDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TWO ROTH RETRIEVAL NETS MALFUNCTIONED DURING PROCEDURE. ONE WOULD NOT DETACH FROM SUPPLY BAG AND THE OTHER WOULD NOT FULLY OPEN. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229464 ROTHNET RETRIEVER SNARE, FLEXIBLE FDI US ENDOSCOPY GROUP, INC. 1915049
    229465 ROTHNET RETRIEVER SNARE, FLEXIBLE FDI US ENDOSCOPY GROUP, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR