BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROXIMATE LINEAR CUTTER

    MDR report key: 3775927 · Received April 28, 2014

    Report

    Report Number
    3005075853-2014-02895
    Event Type
    Death
    Date Received
    April 28, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. 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. FOLLOW UP INFORMATION REQUESTED: WHAT COLORS OF CARTRIDGES WERE USED? SMALL BOWEL? COLON STUMP? WHAT OTHER DEVICES WERE USED? WHAT WAS THE LOCATION OF THE LEAK? WAS A LEAK TEST PERFORMED IN THE INITIAL PROCEDURE? WHAT WAS THE CONDITION OF THE PATIENT AT THE INITIAL PROCEDURE? WAS THE PROCEDURE ORIGINALLY A LAPAROSCOPIC TO OPEN CONVERSION OR AN OPEN?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A LAPAROSCOPIC RIGHT HEMICOLECTOMY PROCEDURE, INTRA-OPERATIVELY, STAPLER WAS USED FOR ANASTAMOSIS OF SMALL BOWEL AND COLON. NO PROBLEMS WERE NOTED WITH FIRING OR OBSERVATION OF STAPLE LINE. PROCEDURE WAS COMPLETED WITHOUT ISSUES. PATIENT WAS TAKEN BACK TO THEATRE FIVE DAYS LATER WITH A LEAK IN THE AREA OF STAPLE LINE AT THE AREA OF ANASTOMOSIS. THE PATIENT WAS NOT IN A GOOD STATE AND THE SURGEON HAD TO RESET THE ANASTAMOSIS LEAVING A STAPLED SMALL BOWEL AND A STAPLED COLON STUMP. PATIENT¿S ABDOMEN WAS NOT CLOSED AND VAC DRESSING WAS USED TO CLEAR INFECTION IN THE ABDOMEN. PATIENT PASSED AWAY FROM A CARDIAC AND LIVER INFARCT. ONE DEVICE WAS DISCARDED; BUT RELOAD UNIT WILL BE RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NO RESPONSE HAS BEEN RECEIVED TO DATE, A SUPPLEMENTAL REPORT WILL BE SENT UPON RECEIPT OF ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254095 PROXIMATE LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death RELOAD TCR10