BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT, 100 MM

    MDR report key: 1080029 · Received July 17, 2008

    Report

    Report Number
    3005075853-2008-00559
    Event Type
    Malfunction
    Date Received
    July 17, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 24, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D4; H4,6: INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE FIRED SOME MALFORMED STAPLES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT, 100 MM GDW ETHICON ENDO-SURGERY, LLC NA D4JH15

    Patients

    Seq Age Sex Outcome Treatment
    1