BEUDAMED
    FDA Adverse Event Death Summary report: N

    ETS LINEAR CUTTER

    MDR report key: 4191746 · Received October 22, 2014

    Report

    Report Number
    3005075853-2014-07277
    Event Type
    Death
    Date Received
    October 22, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 1, 2014
    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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS THE BLOOD LOSS AN ACUTE EVENT? YES. WERE THERE NO STAPLES IN THE AREA OR MALFORMED STAPLES? YES. THE SURGEON SAID NO STAPLE WAS FOUND WHEN THE CHEST WAS OPENED DURING RESCUE OPERATION. WAS THE BLEEDING FROM THE STAPLE CUT LINE OR SOMEWHERE ELSE? FROM THE CUTLINE. WERE ANY IRREGULARITIES NOTICED WITH DEVICE IN THE ORIGINAL PROCEDURE? NO. WAS THE PATIENT STILL INTUBATED? HYPERTENSIVE? COUGHING? WHAT WAS THE PATIENTS AGE AND INDICATIONS FOR SURGERY? THE PATIENT IS 72 YEARS OLD, AND HAD LUNG CANCER. WAS THE PATIENT UNDERGOING CHEMO OR RADIATION THERAPY? UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION IS UNAVAILABLE. 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: BASED ON THE VISUAL EVIDENCE PROVIDED IN THE PHOTO ALONE, THE EVENT DESCRIPTION CANNOT BE CONFIRMED. THERE IS NOT ENOUGH EVIDENCE TO DETERMINE THE CAUSE OF THE COMPLAINT. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WAS THE BLOOD LOSS AN ACUTE EVENT? WERE THERE NO STAPLES IN THE AREA OR MALFORMED STAPLES? WAS THE BLEEDING FROM THE STAPLE CUT LINE OR SOMEWHERE ELSE? WERE ANY IRREGULARITIES NOTICED WITH DEVICE IN THE ORIGINAL PROCEDURE? WAS THE PATIENT STILL INTUBATED? HYPERTENSIVE? COUGHING? WHAT WAS THE PATIENT¿S AGE AND INDICATIONS FOR SURGERY? WAS THE PATIENT UNDERGOING CHEMO OR RADIATION THERAPY?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON USED THE DEVICE TO TRANSECT THE VEIN OF LEFT UPPER LOBE OF LUNG AT 11:00 AM. THE CUT LINE AND B-FORMED STAPLE LINE WERE DEPLOYED AS EXPECTED. NO BLEEDING WAS FOUND AT THE VEIN. THE PROCEDURE WAS COMPLETED AT 12:00 PM. THE PATIENT WAS MOVED TO ICU FOR OBSERVATION. THE BLOOD PRESSURE DROPPED AT 12:48 PM, MUCH BLOOD EFFUSED FROM THE DRAINAGE TUBE. THE PATIENT WAS HEMORRHAGIC SHOCK AND CARDIAC ARREST. THE PATIENT WAS SENT TO OPERATION ROOM FOR EMERGENCY TREATMENT AT 1:00 PM. THE CHEST WAS OPENED AND NO STAPLE WAS FOUND ON THE VEIN OF LEFT UPPER LOBE OF LUNG. THE SURGEON USED HAND SEWING TO LIGATE THE VEIN. CARDIORESPIRATORY RESUSCITATION AND BLOOD TRANSFUSION WAS TAKEN. THE BLOOD PRESSURE ROSE UP AND THE HEARTBEAT APPEARED AT 13:15 PM. AFTER 30 MINUTES EMERGENCY TREATMENT, THE BLOOD PRESSURE DROPPED AGAIN AND ATRIAL FIBRILLATION APPEARED. CARDIORESPIRATORY RESUSCITATION AND PRESSURIZED BLOOD TRANSFUSION WAS TAKEN, BUT THE HEARTBEAT DISAPPEARED AND THE PATIENT WAS DEAD AT LAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671699 ETS LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR