BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSHING, 19CM (7.50"), 0.7MM

    MDR report key: 710105 · Received May 3, 2006

    Report

    Report Number
    2430952-2006-00018
    Event Type
    Malfunction
    Date Received
    May 3, 2006
    Report Date
    May 1, 2006
    Manufacturer
    J. JAMNER SURGICAL INSTRUMENTS, INC.
    Product Code
    LYT
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THAT ON THE CUSHING STYLE BIPOLAR, THE END OF THE BIPOLAR BEGIN TO SEPARATED WHEN PUSHING THE TWO SIDES TOGETHER ALL THE WAY.

    Description of Event or Problem · 1

    PRODUCT ID FOR DEVICE RECEIVED WAS IDENTIFIED AS N19C15 NOT N19C07 AS INITIALLY REPORTED. THE MFR OF THE DEVICE HAS BEEN IDENTIFIED AND PROVIDED HEREIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSHING, 19CM (7.50"), 0.7MM NON-STICK BIPOLAR LYT J. JAMNER SURGICAL INSTRUMENTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *