BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION HANDLE AND COAGULATOR

    MDR report key: 20723640 · Received November 18, 2024

    Report

    Report Number
    MW5162628
    Event Type
    Malfunction
    Date Received
    November 18, 2024
    Date of Event
    November 14, 2024
    Report Date
    November 14, 2024
    Manufacturer
    CAMERON-MILLER, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SEVERAL ISSUES, INCLUDING CRACKS, PITTING, RUST, GOUGES, DAMAGED EDGES ON INSTRUMENTS, DELIVERED IN SOILED AND DEGRADED PACKAGING, AND BLACK DEBRIS THAT APPEARS TO BE OLD CHAR INSIDE THE PACKAGING OF THE INSTRUMENTS WITH CAMERON-MILLER BRAND ENT PRODUCTS (26-1104, 26-1105). MEDICAL EQUIPMENT IFU (INSTRUCTIONS FOR USE) APPEARS TO BE OUTDATED, AND VALIDATION METHODS ARE QUESTIONABLE. REF REPORT: MW5162627.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2070657 SUCTION HANDLE AND COAGULATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CAMERON-MILLER, INC. 26-1104

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown