BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 2945294 · Received February 6, 2013

    Report

    Report Number
    3005075853-2013-00498
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 17, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED ANVIL. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: IN REFERENCE TO THE DEVICE FAILING TO CUT NORMALLY, DID THE DEVICE PRODUCE A JAGGED, ROUGH, CROOKED, IRREGULAR OR RIPPED CUT LINE? WAS THE CUT LINE COMPLETE OR PARTIAL? WHERE THE DEPLOYED STAPLES FORMED? WAS THERE AN INTERRUPTION OF THE STAPLE LINE? HOW MUCH BLOOD WAS LOSS? DID THE PATIENT REQUIRE A BLOOD TRANSFUSION? WAS THE PATIENT ON ANTICOAGULATION THERAPY? HOW DID THE SURGEON GAIN CONTROL OF THE BLEEDING? HOW WAS THE DAMAGE TO THE STOMACH TISSUE RESOLVED? PLEASE CLARIFY THE STATEMENT 'THE STAPLE LINE APPEARED SUB OPTIMAL.' WAS THERE ANY UNEXPECTED NOISES HEARD? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? WHAT IS THE CURRENT STATUS OF THE PATIENT? THE ANALYSIS FOUND THAT ONE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE RELOAD LOADED ON THE DEVICE. 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. EVENT COULD NOT BE CONFIRMED AS NO MALFORMED STAPLES WERE NOTED DURING FUNCTIONAL TESTING. PLEASE ENSURE THAT THE TISSUE LIES FLAT AND IS POSITIONED PROPERLY BETWEEN THE JAWS. ANY BUNCHING OF TISSUE ALONG THE RELOAD, PARTICULARLY IN THE CROTCH OF THE JAWS, MAY RESULT IN AN INCOMPLETE STAPLE LINE. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. 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 SLEEVE GASTRECTOMY PROCEDURE ON THE 4TH FIRING, THE SURGEON ATTEMPTED TO FIRE A BLUE CARTRIDGE OVER AN EXISTING STAPLE LINE. THE DEVICE FAILED TO CUT AND FORM STAPLES NORMALLY AND INSTEAD SEEMINGLY PUSHED THE TISSUE OUT TOWARDS THE DISTAL END OF THE INSTRUMENT. WHEN THE JAWS WERE OPENED, THERE WAS VISIBLE TEARING OF THE STOMACH TISSUE AND A SIGNIFICANT AMOUNT OF BLEEDING. THE SURGEON MANAGED TO GAIN CONTROL OF THE BLEEDING AND REPAIR THE DAMAGE TO THE STOMACH TISSUE. THE SAME STAPLER WAS THEN USED FOR THE NEXT (5TH) FIRING, AS IT WAS THOUGHT THAT POTENTIALLY CROSSING STAPLE LINES HAD BEEN THE CAUSE OF THE PREVIOUS MISFIRE. THIS TIME THE STAPLER CUT AS INTENDED, BUT UPON CLOSE INSPECTION, THE STAPLE LINE APPEARED SUB OPTIMAL AND ANOTHER SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. A METHYLENE BLUE LEAK TEST WAS PERFORMED SUCCESSFULLY. NO BUTTRESS MATERIAL WAS USED AND THE 1ST 3 FIRINGS (ALL GREEN) HAD APPEARED TO FORM STAPLES PROPERLY, ALTHOUGH THERE WAS SOME BLEEDING FROM THE 3RD FIRING WHICH HAD TO BE SUTURED BEFORE CONTINUING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51042 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4C68C

    Patients

    Seq Age Sex Outcome Treatment
    1