BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT

    MDR report key: 1003621 · Received February 15, 2008

    Report

    Report Number
    1527736-2008-00933
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 25, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SIGMOIDECTOMY PROCEDURE, THE ELEMENTARY PART OF THE STAPLE DID NOT COMPLETE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT GDW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1