BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN STAPLING DEVICE

    MDR report key: 3775646 · Received April 15, 2014

    Report

    Report Number
    1219930-2014-00303
    Event Type
    Death
    Date Received
    April 15, 2014
    Date of Event
    March 26, 2012
    Report Date
    March 27, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GAG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: OPEN SLEEVE GASTRECTOMY. ACCORDING TO THE REPORTER: ON OR ABOUT (B)(6) 2012, THE DECEDENT UNDERWENT AN OPEN SLEEVE GASTRECTOMY FOR MORBID OBESITY. AS PART OF THE SURGICAL PROCEDURE PERFORMED, THE SURGEON TRANSECTED THE STOMACH USING A STAPLING DEVICE AND STAPLE LOADING UNITS. ON (B)(6) 2012, THE DECEDENT DEVELOPED TACHYCARDIA WITH SHORTNESS OF BREATH AND SHARP PAIN UNDER HER LEFT BREAST. AFTER A PULMONARY EMBOLISM WAS RULED OUT, AN UPPER G1 WAS ORDERED AND WAS POSITIVE FOR A LEAK. THE DECEDENT WAS TAKEN INTO THE OPERATING ROOM WHERE THE SURGEON PERFORMED A DIAGNOSTIC LAPAROSCOPY AND FOUND THE STAPLE LINE HAD SEPARATED. THE DRAINAGE WAS MANAGED IN THE ICU WHERE SHE THEN DEVELOPED A MASSIVE WOUND DEHISCENCE AND OTHER COMPLICATIONS REQUIRING EXTENSIVE SURGERY RESULTING IN DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231036 UNKNOWN STAPLING DEVICE SURGICAL STAPLING DEVICE GAG COVIDIEN, FORMERLY US SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| O