BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 6124238 · Received November 23, 2016

    Report

    Report Number
    3005075853-2016-06686
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 9, 2016
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE ATS45 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A TR45W CARTRIDGE LOADED IN THE DEVICE. 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 OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND NO ANOMALIES WERE FOUND. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH/LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. 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. ADDITIONAL INFORMATION REQUESTED AND RECEIVED: WHAT TROUBLESHOOTING STEPS WERE TAKEN TO OPEN THE DEVICE PRIOR TO CUTTING IT OUT? MANUALLY TRIED TO OPEN DEVICE USING RELEASE BUTTON ON BACK OF DEVICE AND HANDLE COMPRESSION WITH RELEASE. MANUAL STEPS TO PRY HANDLE AWAY FROM STERILE GRIP TAKEN AS WELL. WAS THE DEVICE DIFFICULT TO CLOSE? WAS THE DEVICE DIFFICULT TO FIRE? DEVICE WAS NOT DIFFICULT TO FIRE BUT DOC REPEATED "I MIGHT HAVE TAKEN A LITTLE TOO LARGE OF A BITE" WAS THE FIRING ABLE TO BE COMPLETED? THE FIRING WAS ABLE TO BE COMPLETED, YES. THIS WAS THE EIGHTH FIRE. WAS THE EXTENDED HOSPITAL STAY AND ANTIBIOTICS DUE TO DEVICE ISSUE OR WAS IT STANDARD PROTOCOL FOR PROCEDURE? EXTENDED HOSPITAL STAY AND ANTIBIOTICS WAS DUE TO DEVICE ISSUE. ANTIBIOTICS STARTED BECAUSE ANESTHESIA LASTED FOR LONGER THAN 4 HOURS, DUE TO STAPLER ISSUE. IT IS PROTOCOL IN THIS HOSPITAL THAT SURGERIES LASTING FOR LONGER THAN FOUR HOURS, ANTIBIOTICS WILL BE GIVEN. DID THE BLOOD LOSS OCCUR IMMEDIATELY OR DURING THE ATTEMPTS TO REMOVE? BLOOD LOSS OCCURRED DURING THE ATTEMPT TO REMOVE THE STAPLER. WHAT IS THE CURRENT PATIENT STATUS? CURRENT PATIENT STATUS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC NEPHRECTOMY PROCEDURE THE DEVICE CLOSED ON THE ADRENAL ARTERY, FIRED, BUT WOULD NOT OPEN WHEN THE TRIGGER WAS RELEASED. THE SURGEON USED A HAR36 TO CUT AROUND THE DEVICE IN ORDER TO REMOVE IT. IT IS UNKNOWN IF IT CUT OR STAPLED PROPERLY SINCE THEY WERE UNABLE TO OPEN THE DEVICE. THERE WAS APPROXIMATELY ONE LITER OF BLOOD LOSS, HOWEVER NO TRANSFUSION WAS REQUIRED. THE SURGEON TIED OFF THE ARTERY WITH UNKNOWN SUTURE TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS PROLONGED APPROXIMATELY 1 1/2 HOURS. THE PATIENT HAS BEEN GIVEN ANTI-BIOTIC AND IS STILL IN THE HOSPITAL AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775658 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention