BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCSCOPIC LINEAR CUTTER (STANDARD) - 35 MM

    MDR report key: 1831747 · Received January 15, 2008

    Report

    Report Number
    1527736-2008-00272
    Event Type
    Malfunction
    Date Received
    January 15, 2008
    Date of Event
    December 31, 2007
    Report Date
    January 3, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY THE DEVICE CARTRIDGE PAN SEPARATED OFF OF THE RELOAD. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOCSCOPIC LINEAR CUTTER (STANDARD) - 35 MM GDW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4GM3U

    Patients

    Seq Age Sex Outcome Treatment
    1