BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOTOME¿ RX 44

    MDR report key: 20211236 · Received September 13, 2024

    Report

    Report Number
    20211236
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    March 31, 2024
    Report Date
    May 27, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    UDI-DI
    08714729444749
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE NURSE MNAGER OF GI NOTIFIED ME THAT THE SUPPLY OF AUTOTOM RX 44 APPEARED DIRTY AND RUSTY DESPITE THE PACKAGING BEING INTACT. THE NURSE MANAGER NOTIFIED THE REP. FROM BOSTON SCIENTIFIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1563285 AUTOTOME¿ RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION M00545170 33280747 08714729444749

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown