BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECHELON CODE UNKNOWN

    MDR report key: 2862695 · Received December 10, 2012

    Report

    Report Number
    3005075853-2012-05489
    Event Type
    Death
    Date Received
    December 10, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 8, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE DOCTOR HAS SUGGESTED THAT THERE WAS A SEVERE GASTRIC LEAK. ADDITIONAL INFORMATION PROVIDED: DATE OF FIRST SURGERY (GASTRIC SLEEVE)? UNKNOWN. WHAT KIND OF DEVICE WAS USED IN THE PROCEDURE (GASTRIC SLEEVE)? ECHELON FLEX. WHERE THERE ANY PROBLEMS NOTICED DURING THE FIRST SURGERY (GASTRIC SLEEVE)? NOTHING NOTED. HOW LONG HAS THE SURGEON BEEN USING THIS DEVICE FOR THIS PROCEDURE (IN YEARS)? APPROXIMATELY 2 YEARS. WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR WITH THIS SURGEON? NO. WHY WAS THE PATIENT BROUGHT INTO A+E ON (B)(6) 2012, PLEASE DESCRIBE EXACTLY? UNKNOWN. WHAT EXACTLY CAUSED THE DEATH? AWAITING CORONER'S REPORT. DID BLEEDING OCCUR? NOT AT THE TIME OF SURGERY. WHAT WERE THE PATIENT'S HEALTH STATUS AND PRE-OP DIAGNOSIS BEFORE THE FIRST SURGERY? UNKNOWN. PATIENT, AGE, AND WEIGHT? UNKNOWN. BARIATRIC MANAGER HAS SPOKEN WITH THE SURGEON WHO PERFORMED THE SLEEVE GASTRECTOMY AND HE NOTED NO DIFFICULTIES WITH THE DEVICE AND THE STAPLE LINE WAS SECURE AT THE TIME OF THE PROCEDURE. THE BARIATRIC UNITS HAVE INCORPORATED IMPROVEMENTS TO EMERGENCY CARE FOR POST OP BARIATRIC PATIENTS AND THESE IMPROVEMENTS ARE NOT RELATED TO THE USE OF STAPLING DEVICES. THEY DO NOT BELIEVE THE OUTCOME TO THIS PATIENT WAS RELATED TO THE DEVICE FUNCTION OR USE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A GASTRIC SLEEVE PROCEDURE THE DOCTOR INFORMED THAT A PATIENT WAS BROUGHT INTO A+E ON SUNDAY, (B)(6) 2012. THE FEMALE PATIENT HAD PREVIOUSLY UNDERGONE A GASTRIC SLEEVE PROCEDURE AT (B)(6) HOSPITAL 2 WEEKS PRIOR TO BEING ADMITTED TO WYCOMBE GENERAL. THE PATIENT WAS TAKEN INTO THEATRES ON (B)(6) 2012 AND DIED IN THEATRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON CODE UNKNOWN STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK BATCH # UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death