BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EGIA 60 ARTICULATING MED/THICK SULU

    MDR report key: 5216879 · Received November 11, 2015

    Report

    Report Number
    1219930-2015-00993
    Event Type
    Malfunction
    Date Received
    November 11, 2015
    Date of Event
    October 20, 2015
    Report Date
    October 21, 2015
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE RELOAD. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, AND AN EVALUATION OF THE RETURNED DEVICES. VISUAL INSPECTION OF THE CARTRIDGE REVEALED THAT THE RELOAD WAS FULLY FIRED. THE RELOAD WAS LOADED INTO A PMV REPRESENTATIVE INSTRUMENT FOR FUNCTIONAL TESTING. THE RELOAD WAS CYCLED WITHOUT HESITATION OR BINDING AFTER OVERRIDING THE INTERLOCK. FUNCTIONAL TESTING CONFIRMED THE SAFETY INTERLOCK FEATURE SUCCESSFULLY PREVENTED THE RELOAD FROM CYCLING AGAIN. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    THIS FTR RELATES TO (B)(4) PROCEDURE: OPEN LAW ANTERIOR RESECTION / DOUBLE STAPLING. CUSTOMER STATES THAT AFTER THE FIRST FIRE TO THE COLON ON THE MOUTH SIDE WAS DONE WITH NO PROBLEM USING IDRIVE AND 60AMT, THE SURGEON MADE THE SECOND FIRE TO THE RECTAL WITH THE SECOND 60AMT; HOWEVER, THE FIRING WAS STOPPED AT THE 2CM ADVANCED. PUSHING THE BLUE BUTTON AGAIN, THE DEVICE DID NOT START FIRING. THE DEVICE WAS REMOVED FROM THE TISSUE WITH PUSHING THE SILVER BUTTON. THE RECTAL WAS STAPLED AND DISSECTED A LITTLE. UPON THE THIRD FIRE TO THE MOUTH SIDE OF THE PREVIOUS STAPLE LINE WITH THE THIRD 60AMT, THE DEVICE STOPPED AT THE 2CM ADVANCED AGAIN. AFTER A WHILE, THE SURGEON PUSHED THE BLUE BUTTON, THEN THE CLAMP COVER ADVANCED SLIGHTLY WITH A WEAK SOUND, AND STOPPED. DUPLICATED THE SAME ISSUE 3 OR 4 TIMES WITH A WEAK SOUND, THE DEVICE STOPPED WORKING AT 3 OR 4CM ADVANCED. THE DEVICE WAS REMOVED FROM THE TISSUE WITH PUSHING THE SILVER BUTTON. THE FIRING HAS BEEN MADE AT THE HALF OF THE RECTAL. THE NEW HANDLE AND ADAPTER WERE OPENED WITH 45AMT, AND THE FIRING WAS DONE WITHOUT FIRING SPEED LOSS. AT THE TIME OF STOPPING THE FIRING, THE FIRING SPEED WAS SLOWER AND THE FIRING SOUND WAS WEAKER; THE JAWS WERE ARTICULATED MAXIMUM TO THE LEFT WITH THE ANVIL ONTO THE DORSAL SIDE. EVERY SELF-CHECK HAD NO ABNORMALITY; THE TISSUE THICKNESS: NORMAL (THE SURGEON CONFIRMED IT ON PALPATION OF THE RECTAL BEFORE FIRING AND THE SPECIMEN AFTER DISSECTION). REINFORCEMENT MATERIAL USE IN CONJUNCTION: NO. GENDER: MALE. AGE AND WEIGHT: NOT PROVIDED. LAST PATIENT'S STATUS: UNDER OBSERVATION. OPERATING TIME EXTENDED: LESS THAN 30 MIN. NOTHING FELL INTO THE CAVITY. NO BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747405 EGIA 60 ARTICULATING MED/THICK SULU DISPOSIBLE STAPLING RELOAD GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON EGIA60AMT N5C1454KX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S