BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO ILS, 29MM, CURVED

    MDR report key: 2861921 · Received December 7, 2012

    Report

    Report Number
    3005075853-2012-05505
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 14, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH# J5J921. EXPIRATION DATE 8/27/2017. MANUFACTURING DATE: 9/27/2012. FOUR DEVICES (A-D) WERE RETURNED FOR ANALYSIS. DEVICES A, B AND D ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WERE PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICES ACHIEVED A FULL FIRING STROKE. THE DEVICES WERE RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICES AND THEY WERE TESTED FOR FUNCTIONALITY. THEY FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINES WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. DEVICE C ARRIVED IN GOOD VISUAL CONDITION, FULLY LOADED WITH STAPLES AND WITH THE BREAKAWAY WASHER UNCUT, INDICATING THAT THE DEVICE HAD NOT BEEN FIRE. THE DEVICE WAS TESTED FOR FUNCTIONALITY AND IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. IT SHOULD BE NOTED THAT TO REMOVE THE DEVICE AFTER A COMPLETE FIRING STROKE, OPEN THE INSTRUMENT BY TURNING THE ADJUSTING KNOB COUNTERCLOCKWISE. FOR EASY REMOVAL, ONLY OPEN THE INSTRUMENT ONE-HALF TO THREE-FOURTHS REVOLUTIONS. TO ASSURE THE ANVIL IS FREE FROM TISSUE, ROTATE THE INSTRUMENT 90° IN BOTH DIRECTIONS. TO WITHDRAW THE OPEN INSTRUMENT, GENTLY APPLY REARWARD TRACTION WHILE SIMULTANEOUSLY ROTATING. PLEASE REFERENCE THE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT DURING AN EXPLORATORY LAPAROSCOPY PROCEDURE FOR BLEEDING IN LEFT COLON ULCER, AFTER FIRING THE FIRST DEVICE THERE WAS A LEAK. A SECOND DEVICE WAS FIRED AND THE BOWEL TORN WHEN EXTRACTING DEVICE FROM THE RECTUM AS THEY WERE DIFFICULT TO REMOVE. THAT PORTION OF THE BOWEL WAS RESECTED THE SURGEON TRIED TO OVER SEW THE TISSUE AND THERE WAS STILL A LEAK. THE ANASTOMOSIS WAS REDONE. A THIRD DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO ILS, 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CF0C

    Patients

    Seq Age Sex Outcome Treatment
    1