BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICULATING LINEAR CUTTER

    MDR report key: 3842692 · Received June 2, 2014

    Report

    Report Number
    3005075853-2014-03601
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 5, 2014
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT WAS THE NAME OF THE PROCEDURE? NEPHRECTOMY. PLEASE QUANTIFY THE AMOUNT OF BLOOD LOSS. > 75MLS. DID THE PATIENT REQUIRE A BLOOD TRANSFUSION? NO IF YES, HOW MUCH BLOOD WAS TRANSFUSED? WHAT WAS DONE TO CONTROL THE BLEEDING WHEN THE ARTERY WAS CUT BUT NOT STAPLED? CLAMPED AND SECOND DEVICE USED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A CARTRIDGE PRESENT. THE RELOAD WAS RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, 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. EVENT COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED DURING THE FUNCTIONAL TESTING. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE CUT THE RENAL ARTERY BUT DID NOT STAPLE COMPLETELY. THE PROCEDURE COMPLETED WITH SAME/LIKE DEVICE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320772 ARTICULATING LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4EO4U

    Patients

    Seq Age Sex Outcome Treatment
    1