BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO ILS, 29MM, CURVED

    MDR report key: 3122774 · Received May 21, 2013

    Report

    Report Number
    3005075853-2013-02475
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    March 22, 2013
    Report Date
    May 1, 2013
    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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: WHAT PURSE STRING TECHNIQUE WAS USED? HAND SEWN. WHEN THE DEVICE WAS FIRED, WHAT WAS THE LOCATION OF THE INDICATOR WITHIN THE GAP SETTING SCALE? JUST INSIDE THE GREEN AT THE LARGEST SETTING. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? YES, NEAR DISTAL SIGMOID COLON TRANSECTION. HOW DID YOU CONFIRM THE DEVICE WAS FULLY FIRED (SUCH AS CRUNCH, COMPRESSED UNTIL UNABLE TO FIRE FURTHER, ETC.)? CRUNCH WAS HEARD AND FELT. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING)? NO. WAS A LEAK TEST PERFORMED? NOT INITIALLY, BECAUSE ANASTOMOSIS FELL APART. THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY. 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. THE ANVIL WAS ATTACHED ON THE DEVICE COMPLETELY AND WITHOUT ANY DIFFICULTIES AND DID NOT DETACH DURING FUNCTIONAL TESTING. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    THE SALES REP REPORTS THAT DURING A OPEN SIGMOID RESECTION PROCEDURE, THE DEVICE FIRED INCOMPLETE DONUTS AND INCOMPLETE STAPLE LINE. THE SURGEON REPORTED THAT THE ANASTOMOSIS FELL APART. THE PA WHO FIRED THE ECS29A REPORTED THAT HE FELT AND HEARD THE CRUNCH, HOWEVER AS HE REMOVED THE STAPLER, HE SAID THAT THE ANVIL BECAME UNATTACHED. THE ANVIL THEN WAS REMOVED TRANSANALLY. HE ALSO REPORTED THAT THE TISSUE WAS THICK AND INFLAMED. A SECOND DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ISSUES WITH THE SECOND ANASTOMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224978 ENDO ILS, 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK K4C694

    Patients

    Seq Age Sex Outcome Treatment
    1