BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH STEALTH INTRALUMINAL STAPLER

    MDR report key: 1061166 · Received May 30, 2008

    Report

    Report Number
    1061166
    Event Type
    Malfunction
    Date Received
    May 30, 2008
    Date of Event
    May 30, 2008
    Report Date
    May 30, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING SIGMOID COLECTOMY DUE TO DIAGNOSIS OF COLON CANCER AND ABDOMINAL MASS. DURING THE PROCEDURE THE DEVICE MISFIRED AND DID NOT ALLOW THE STAPLE TO CRIMP FULLY INTO PLACE WHILE CLOSING THE TISSUE. STAPLES REMOVED X 2 FROM PATIENT'S SURGICAL SITE. THE INSTRUMENT WAS REMOVED FROM SERVICE AND THE SURGEON OPTED TO SUTURE THE COLON CLOSED BY HAND. NO INJURY NOTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH STEALTH INTRALUMINAL STAPLER STAPLER, SURGICAL GAG ETHICON ENDO-SURGERY, INC. ECS29 E4KEOP

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR