BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE

    MDR report key: 2012126 · Received March 4, 2011

    Report

    Report Number
    2012126
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 17, 2011
    Report Date
    March 4, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS TAKEN TO SURGERY FOR EXTENSIVE LYSIS OF ADHESIONS AND ILEOCOLOSTOMY BYPASS. UPON THE SURGEON USING THE ETHICON ENDO-SURGERY LINEAR CUTTER THE STAPLER WOULD NOT FIRE. THE SURGEON REMOVED THE STAPLE CARTRIDGE AND OBTAINED ANOTHER STAPLER RELOAD. THIS LOAD FUNCTIONED APPROPRIATELY UNTIL IT WAS OUT OF STAPLES. SURGEON PLACED ANOTHER RELOAD AND UPON ATTEMPTING TO USE IT WOULD NOT COMPLETELY CUT THROUGH THE PATIENT'S TISSUE AS IT IS SUPPOSED TO DO. A THIRD STAPLER RELOAD WAS OBTAINED AND USED TO FINISH THE CASE. THE STAPLER AND TWO MALFUNCTIONING RELOADS WERE SEQUESTERED FOR RISK. THE CASE WAS FINISHED AND THE PATIENT WAS SENT TO THE PACU FOR RECOVERY. UNFORTUNATELY ONLY THE STAPLER BOX WAS SAVED SO UNABLE TO DETERMINE LOT NUMBERS TO RELOADS. NO INJURY TO THE PATIENT, JUST A DELAY IN OBTAINING REPLACEMENT DEVICES WHILE THE PATIENT WAS UNDERGOING PROCEDURE.MANUFACTURER RESPONSE FOR STAPLE, CUTTER, SURGICAL, PROXIMATE: REPRESENTATIVE CAME TO VISUALLY INSPECT PRODUCT. FELT PROBLEM WAS LIKELY WITH STAPLER COMPONENT RATHER THAN RELOAD.MANUFACTURER RESPONSE FOR STAPLE, RELOAD, SURGICAL, PROXIMATE: REPRESENTATIVE CAME TO VISUALLY INSPECT PRODUCT. FELT PROBLEM WAS LIKELY WITH STAPLER COMPONENT RATHER THAN RELOAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE STAPLER, CUTTER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. NTLC75 G4U82L
    2 PROXIMATE STAPLER, RELOAD, SURGICAL GDW ETHICON ENDO-SURGERY, INC. SR75 *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR