BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULATING LINEAR CUTTER

    MDR report key: 3181469 · Received June 21, 2013

    Report

    Report Number
    3005075853-2013-03166
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? DURING WHICH STROKE DID THE EVENT OCCUR? WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? WAS THE DEVICE RINSED IN BETWEEN RELOADS? STAPLE FORM OR NO STAPLES? DAMAGE ON BOTH SIDES OR ONLY ONE? WAS ANY DAMAGE NOTED ON THE CARTRIDGE DECK? THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO RELOAD PRESENT ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED THE STAPLES AS INTENDED. THE DEVICE FIRED 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 NO CARTRIDGE WAS RECEIVED FOR ANALYSIS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT VAPS UPPER LOBECTOMY PROCEDURE, WHILE TRANSECTING THE TRUNCUS ANTERIOR ARTERY, THE SURGEON FOUND THAT IT WAS SLIGHTLY HARDER TO SQUEEZE THE FIRING TRIGGER AFTER CLOSING THE STAPLER JAWS ON THE TISSUE. UPON RELEASING THE STAPLE JAW, THERE WAS A HOLE OBSERVED ON THE STAPLE LINE AND BLOOD STARTED SPURTING OUT OF IT. THE PROCEDURE WAS CONVERTED TO OPEN. THE SURGEON HAD TO CLAMP THE ARTERY AND MAKE THE INCISION LONGER IN ORDER TO SUTURE THE DEFECT. THIS WAS THE THIRD FIRING OF THE DEVICE, THE FIRST TWO FIRINGS WORKED FINE. THE PATIENT IS STABLE AND DOING FINE POST-OPERATIVELY. SURGERY WAS PROLONGED TWENTY MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282210 ARTICULATING LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4CC13

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention