BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT

    MDR report key: 1190749 · Received October 7, 2008

    Report

    Report Number
    3005075853-2008-02158
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 15, 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
    WI, US
    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 THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. THE DEVICE WHEN RELOADED FIRED ONLY (1) STAPLE LINE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS 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, LLC NA E4LE30

    Patients

    Seq Age Sex Outcome Treatment
    1