BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 5101182 · Received September 24, 2015

    Report

    Report Number
    2647580-2015-00677
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    August 24, 2015
    Report Date
    August 31, 2015
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GAG
    PMA / PMN Number
    K001895
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF TWO DEVICES OPENED BY THE ACCOUNT. 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. THE REPORTED CONDITION FOR THIS INCIDENT WAS THAT THE INSTRUMENT DID NOT FIRE DURING THE COLECTOMY PROCEDURE. THE VISUAL INSPECTION OF THE STAPLE GUIDES NOTED THE INSTRUMENTS WERE FULLY APPLIED. THE ANVIL OF ONE INSTRUMENT WAS OBSERVED TO BE NOT TILTED AND ATTACHED TO THE INSTRUMENT. NO KNIFE IMPRESSION WAS OBSERVED ALONG THE CUTLINE IMPRESSION IN THE CUTTING RING/MYLAR COVER. FUNCTIONALLY, THE DEVICES WERE APPLIED OVER THE APPROPRIATE TEST MEDIA PRODUCING ACCEPTABLE RESULTS. THE KNIVES CUT THE TEST MEDIA CLEANLY AND COMPLETELY, AND THE PUSHERS ADVANCED. FUNCTIONAL TESTING OF THE RETURNED SAMPLES CONFIRMED THE PRODUCTS MET QUALITY RELEASE SPECIFICATIONS THAT WERE TESTED REGARDING THE REPORTED CONDITION AND THE REPORTED CONDITION WAS NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL COVIDIEN QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. REPLICATION OF THE SECONDARY, UNRELATED TO THE REPORTED CONDITION, CONDITION MAY OCCUR IF THE INSTRUMENT HANDLE COMPRESSION IS NOT COMPLETED OR IF THE INSTRUMENT IS APPLIED AGAINST AN EXCESSIVE AMOUNT OF TISSUE DURING THE CLINICAL APPLICATION. ALSO, THE INSTRUCTIONS FOR USE OF THIS PRODUCT STATES: WHEN FIRING THE STAPLER, MAKE SURE TO FULLY SQUEEZE THE INSTRUMENT HANDLE UNTIL THE METAL UNDERSIDE OF THE HANDLE CONTACTS THE STAPLER BODY TO THE FULLEST EXTENT. PARTIAL OR INCOMPLETE HANDLE SQUEEZES MAY RESULT IN UNACCEPTABLE STAPLE FORMATION AND/OR INCOMPLETE KNIFE CUT. THEREFORE, NO ENHANCEMENTS OR IMPROVEMENTS WERE GENERATED FOR THE REPORTED CONDITION. THE FILE WILL BE CLOSED AS NOT CONFIRMED. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY AMENDED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A RECTUM RESECTION, TWO CLIP INSTRUMENTS DID NOT FIRE CORRECTLY AND A NEW INSTRUMENT WAS USED. THE PRESSURE PLATE OF THE EEA INSTRUMENT WAS INTRODUCED IN THE DISTAL COLON AND FIXED. THE EEA INTRODUCED TRANSANAL INTO THE RECTUM AND THE CENTRAL BOLT WAS EXTENDED. THE CONNECTION BETWEEN THE PRESSURE PLATE AND THE EEA INSTRUMENT WAS DIFFICULT. DURING CLOSURE OF INSTRUMENT, THE PRESSURE PLATE DISCONNECTED. SEVERAL ATTEMPTS WERE MADE, BUT THE PRESSURE PLATE AND CENTRAL BOLT WERE ALWAYS DISCONNECTING. AT THIS POINT, A NEW EEA WAS USED. THE OLD PRESSURE PLATE WAS REMOVED BY RE-DISSECTION OF TISSUE AND THE OLD EEA WAS REMOVED. NEXT, A NEW PRESSURE PLATE WAS PLACED AND FIXED AND A NEW EEA STAPLER WAS INTRODUCED TRANSANAL AND THE CENTRAL BOLT WAS EXTENDED. AT THIS POINT, THE PRESSURE PLATE COULD BE CONNECTED, BUT DURING CLOSURE OF INSTRUMENT, THE PRESSURE PLATE DISCONNECTED AGAIN. THEN SURGEON CHANGED TO A COMPETITOR INSTRUMENT. SURGICAL TIME WAS DELAYED BY MORE THAN 30 MINUTES AND THERE WAS EXTENSION OF INCISION BY MORE THAN ONE INCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633448 EEA 31MM SINGLE-USE STAPLER STAPLER, SURGICAL GAG COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA31 P5C0123KX

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other