BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROXIMATE PPH PROCEDURE SET

    MDR report key: 1611858 · Received February 19, 2010

    Report

    Report Number
    3005075853-2010-00739
    Event Type
    Death
    Date Received
    February 19, 2010
    Date of Event
    January 26, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051301
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT DURING A RECTAL MUCOSAL PROLAPSE PROCEDURE, THE FIRING HANDLE COULD NOT BE GRASPED COMPLETELY AND THE DEVICE COULD NOT BE FIRED. THE DOCTOR COMMENTED THAT HE HAD USED THE DEVICE AS USUAL AND FELT NO DIFFICULTIES AT THE FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PT. ADD'L INFO RECEIVED ON 2/3/2010. ON (B) (6) 2010 (OPERATION DATE): THE DOCTOR COULD NOT CUT THE WASHER COMPLETELY AND HE FELT DIFFICULTIES AT THE FIRING. AFTER THE FIRING, HE NOTICED THAT THE TISSUE (12 TO 3 O'CLOCK) WAS NOT CUT. ADD'L SUTURE WAS PERFORMED BY HAND AND COMPLETE THE CASE. THE PT LEFT THE HOSPITAL. ON (B) (6 )2010: THE PT VISITED THE HOSPITAL FOR PAIN IN THE GROIN. THE DOCTOR DOUBTED THE ANESTHESIA. ON (B) (6) 2010: THE PT WAS TRANSPORTED BY AMBULANCE TO THE HOSPITAL. ON (B) (6) 2010: CT SCAN WAS PERFORMED AND THE DOCTOR CONFIRMED THAT THE ANASTOMOSIS SITE WAS LACERATED. AS THE PT WAS LOW PRESSURE AT THE TIME, THE DOCTOR COULD NOT PERFORM THE REOPERATION. ON (B) (6) 2010: THE PT WAS DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE PPH PROCEDURE SET GDW STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death