BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 3172634 · Received June 17, 2013

    Report

    Report Number
    3005075853-2013-03058
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? SMALL INTESTINE. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? FIFTH FIRING. WHAT COLOR CARTRIDGE WAS BEING USED? BLUE. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? GOLD .3, 1-BLUE. WAS BUTTRESSING MATERIAL UTILIZED? ASKU. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? ASKU. WERE ANY UNEXPECTED NOISES HEARD? ASKU. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? YES. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? NO.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE PLE60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH THE MANUAL OVERRIDE DOOR OUT OF POSITION AND MISSING. HOWEVER, IT HAD NOT BEEN BAILOUT OUT. AN ECR60B PARTIALLY FIRED 1/16. IT IS POSSIBLE THAT WHILE LOADING THE RELOAD, THE CARTRIDGE WAS PUSHED FARTHER BACK THAN THE CARTRIDGE ALIGNMENT STOP WINDOWS RESULTING IN THE KNIFE PUSHING THE ONE PIECE SLED FORWARD AND LOCKING THE CARTRIDGE. IN ADDITION, THE KNIFE WAS NOT FULLY RETRACTED, THUS THE DEVICE WOULD NOT OPEN. THE KNIFE WAS RETURNED TO THE HOME POSITION AND THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE 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. THE REVERSE BUTTON AND MANUAL OVERRIDE WERE NOTE TO BE FULLY FUNCTIONAL. EVENT COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED DURING THE FUNCTIONAL TESTING. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, ON THE FIFTH FIRING WITH A BLUE CARTRIDGE, THE DEVICE WAS CLOSED ON POUCH AND SMALL INTESTINE. THE DEVICE WOULD NOT FIRE. WHEN THEY TRIED TO OPEN THE DEVICE THE REVERSE BUTTON WOULD NOT WORK. WHEN THE REVERSE DID NOT WORK THEY TRIED THE MANUAL OVERRIDE AND THE MANUAL OVERRIDE DID NOT WORK. THE DEVICE WAS PULLED OFF THE TISSUE. THE POUCH STAYED INTACT BUT THE SMALL INTESTINE WAS TORN. A SECOND DEVICE WAS PULLED AND CUT AN ADDITIONAL INCH OFF THE BOWEL TO RECONNECT THE POUCH AND THE SMALL INTESTINE. THE ADDITIONAL INCH OF INTESTINE DID NOT ALTER THE PROCEDURE OR POST-OP CARE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272805 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4CJ7P

    Patients

    Seq Age Sex Outcome Treatment
    1