BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    45MM ARTICNG LNR CUTR/BLUE RLD

    MDR report key: 712386 · Received November 21, 2005

    Report

    Report Number
    1527736-2005-05645
    Event Type
    Malfunction
    Date Received
    November 21, 2005
    Date of Event
    November 3, 2005
    Report Date
    November 18, 2005
    Manufacturer
    ETHICON ENDO SURGERY, INC.(CINCINNSTI)
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC COLECTOMY PROCEDURE, MALFORMED STAPLES. A SECOND RELOAD WAS USED WITH THE SAME PROBLEM. THERE WAS NO PT CONSEQUENCE. IT WAS NOT NOTED HOE THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 45MM ARTICNG LNR CUTR/BLUE RLD ENDO LINEAR CUTTERS - ETS45MM GCJ ETHICON ENDO SURGERY, INC.(CINCINNSTI) NA A4AV0F

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN