BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** ETS45

    MDR report key: 1915439 · Received December 6, 2010

    Report

    Report Number
    3005075853-2010-06890
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 11, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE (B)(4) WAS RETURNED INSTEAD OF (B)(4) THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A (B)(4) RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED AND CUT WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING LAPAROSCOPIC GASTRIC BYPASS THE DEVICE WAS BOTTOMED OUT AGAINST THE TROCAR SEAL. THEY HAD GRASPED THE TISSUE AND CLOSE THE DEVICE. WHEN THE DEVICE WAS FIRED IT MADE A DIFFERENT SOUND, LIKE CLICKING. THE DEVICE WAS OPENED, THE DEVICE FIRED PARTIALLY STAPLES BUT, THE CUT LINE WAS COMPLETE. AT THE DISTAL END THERE WERE NO STAPLES. BLEEDING OCCURRED, NO TRANSFUSION WAS GIVEN. ANOTHER DEVICE WAS PULLED AND FIRED EIGHT TIMES TO COMPLETE THE CASE. THERE WAS NO PATIENT CONSEQUENCE.

    Description of Event or Problem · 1

    THIS COMPLAINT IS THE RESULT OF A CUSTOMER CONTACTING BAXTER. THE CUSTOMER REPORTED PRECIPITATION IN THE DIALYSATE LINE. THE TEMPERATURE SET AT 37 DEGREES WITH A 3 LITER EXCHANGE - NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** ETS45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. G4TROM

    Patients

    Seq Age Sex Outcome Treatment
    1