BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE RELOADABLE LINEAR STAPLER

    MDR report key: 1112645 · Received August 11, 2008

    Report

    Report Number
    3005075853-2008-01071
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLOSTOMY REVERSAL PROCEDURE, THE DEVICE WAS FIRED, BUT NO STAPLES DEPLOYED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE RELOADABLE LINEAR STAPLER GDW ETHICON ENDO-SURGERY, LLC. NA E4KRTJ

    Patients

    Seq Age Sex Outcome Treatment
    1