BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 1822536 · Received September 1, 2010

    Report

    Report Number
    3005075853-2010-05015
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    July 16, 2010
    Report Date
    August 10, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT ONE (B)(4) DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE RELOAD PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE 3-STROKE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A CRE BALLOON DILATATION CATHETER AND AN ALLIANCE II INFLATION SYSTEM WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2010 (PATIENT AGE AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS INFLATED IN THE DUODENUM WITHOUT AN ISSUE. HOWEVER, PRIOR TO REMOVAL, THE BALLOON DID NOT QUICKLY DEFLATE; MULTIPLE ATTEMPTS WERE NEEDED TO FULLY DEFLATE THE BALLOON. THE SAME CRE BALLOON DILATATION CATHETER AND ALLIANCE INFLATION SYSTEM WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO ALLEGED MALFUNCTION OF THE ALLIANCE INFLATION SYSTEM. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ASSISTED SIGMOID COLON RESECTION THE DEVICE CLOSED AND WOULD NOT OPEN. IT IS UNKNOWN HOW THE DEVICE WAS REMOVED FROM THE TISSUE. UNKNOWN HOW THE CASE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK NI

    Patients

    Seq Age Sex Outcome Treatment
    1