BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE HCS PROCEDURE OFR PROLAPSE AND HEMORRHOIDS

    MDR report key: 915210 · Received October 5, 2004

    Report

    Report Number
    1527736-2004-03374
    Event Type
    Malfunction
    Date Received
    October 5, 2004
    Report Date
    September 9, 2004
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE DEVICE WAS USED DURING A HEMORRHOIDECTOMY, THE DEVICE DELIVERED MALFORMED STAPLES. PROCEDURE WAS COMPLETED WITH A LIKE DEVICE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE HCS PROCEDURE OFR PROLAPSE AND HEMORRHOIDS HEMORRHOIDAL CIRCULAR STAPELS GAG ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA V4ZM5D

    Patients

    Seq Age Sex Outcome Treatment
    1 YR