BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ACCESS 55 ARTICULATING LINEAR STAPLER

    MDR report key: 161555 · Received April 2, 1998

    Report

    Report Number
    1527736-1998-01083
    Event Type
    Malfunction
    Date Received
    April 2, 1998
    Date of Event
    January 27, 1998
    Report Date
    February 10, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CONSISTS OF TWO DEVICES, BOTH WERE SENT IN THE SAME CONTAINER, HOWEVER CO HAS BEEN INFORMED THAT ONE OF THE DEVICES IS FOR MEDWATCH# 1527736-1998-996. CO IS UNABLE TO DETERMINE WHICH DEVICE BELONGS TO WHICH MEDWATCH DUE TO THE BATCH AND LOT NUMBERS BEING THE SAME. CO HAS SHOWN BOTH DEVICES UNDER THESE MEDWATCH NUMBERS 1527736-1998-679 AND 1527736-1998-1083 AND SHOWN THE 1527736-1998-996 AS A SOURCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE AX55 WAS USED DURING A PROCTITIS ULCEROSA PROCEDURE. IT WAS REPORTED BY THE SURGEON A SURGICAL CRITICAL DECISION WAS MADE FOR THIS SURGICAL PROCEDURE DEVELOPMENT, A MECHANICAL STAPLER INSTRUMENT WAS USED. THE PURPOSE OF THIS INSTRUMENT IS TO STAPLE THE RECTAL MUNON NEXT TO THE ANUS. AFTER REMOVING COMPLETELY THE RECTUM, THIS PROCEDURE ALLOW TO REBUILD THE INTESTINAL CHANNEL, IT IS DONE BY ANAL ACCESS USING MECHANICAL ANASTOMOSIS. THE PROCEDURE PERFORMED THIS WAY IS QUICK, SAFE AND EASY. WELL, THE INSTRUMENT USED (PROXIMATE ACCESS 55 ARTICULATING LINEAR STAPLER, ETHICON) LACK STAPLE PRESENCE, IN SPITE OF BEING A NEW INSTRUMENT. THE INSTRUMENT WAS TAKEN IN MD'S PRESENCE FROM ITS ORIGINAL STERILE PACKAGE. THIS EVENT CAN BE KNOWN FOR USER ONLY AT THE TIME THE INSTRUMENT IS USED AND THERE IS NO WAY TO MAKE A PREVIOUS CHECK. IN THIS SURGICAL CASE THE CONSEQUENCE OF THE MISFIRING PRODUCED RADICAL CHANGE IN THE NEXT SURGICAL STEPS. IT FORCES USER TO MANEUVER A PROCEDURE THAT INCREASES THE PT RISK, INCREASE THE SURGICAL PROCEDURE IN 2 HOURS AND WITH CONSEQUENCE OF FISTULA SEPSIS PERINEAL, INCONTINENCIA, PERDIDA DE RESERVORIO AND ILEOSTOMIA DEFINITIVA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ACCESS 55 ARTICULATING LINEAR STAPLER LINEAR STAPLERS GAG ETHICON ENDO-SURGERY, INC. NA K48H2Z

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other