BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED ECHELON FLEX

    MDR report key: 5489177 · Received March 9, 2016

    Report

    Report Number
    3005075853-2016-01350
    Event Type
    Injury
    Date Received
    March 9, 2016
    Date of Event
    February 24, 2016
    Report Date
    February 25, 2016
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE PSE60A DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH AN ECR60B CARTRIDGE NOT LOADED ON THE DEVICE; THE RELOAD WAS NOTED TO BE RIGHT SIDE FULLY FIRED, LEFT SIDE PARTIALLY FIRED 1/16. NO OBVIOUS DAMAGE TO THE CARTRIDGE DECK WAS NOTED, WHICH SUGGESTS THE CARTRIDGE, MAY NOT HAVE BEEN FIRED OVER A HARD OBJECT. UPON EVALUATION OF THE RELOAD, THE CARTRIDGE BODY, ONE PIECE SLED AND SOME DRIVERS WERE NOTED TO BE DAMAGED. IN ORDER TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS OF THE RELOAD IT WAS DISASSEMBLED AND THE RELOAD WAS NOTED TO HAVE THE DECK, DRIVERS AND ONE PIECE SLED DAMAGED. VIDEO PROVIDED WAS REVIEWED AND A REVISED DETAIL OF THE VIDEO SHOWED THAT THE ISSUE REPORTED IS CONSISTENT WITH ANALYSIS FINDINGS OF THE RETURNED DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD AND IT 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. AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # N53525. THE BATCH HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WHY WAS THE SMALL INCISION CREATED? WHAT WAS THE MEASUREMENT OF THE SMALL INCISION (LENGTH IN CENTIMETERS)? WAS THE PROCEDURE CONVERTED TO OPEN? WAS THERE ANY CHANGE IN THE POST-OPERATIVE CARE OF THE PATIENT AS A RESULT OF THE EVENT? ARE ANY PHOTOS AVAILABLE (INTRA-OPERATIVE OR OF THE CARTRIDGE)? WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT?

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION REQUESTED AND RECEIVED: WHY WAS THE SMALL INCISION CREATED? --- BECAUSE CLOSURE OF THE UNSTAPLED SITE WAS CONDUCTED VIA THE SMALL INCISION. WHAT WAS THE MEASUREMENT OF THE SMALL INCISION (LENGTH IN CENTIMETERS)? --- NO INFORMATION. WAS THE PROCEDURE CONVERTED TO OPEN? --- YES. WAS THERE ANY CHANGE IN THE POST-OPERATIVE CARE OF THE PATIENT AS A RESULT OF THE EVENT? --- NO. ARE ANY PHOTOS AVAILABLE (INTRA-OPERATIVE OR OF THE CARTRIDGE)? --- YES, THE VIDEO OF INTRA-OPERATIVE WAS RECEIVED AND SENT TO YOU ON (B)(4). WAS BUTTRESSING MATERIAL UTILIZED? --- NO INFORMATION. IF SO, WHICH PRODUCT? --- NA.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # N53525. THE ANALYSIS FOUND THAT ONE PSE60A DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH AN ECR60B CARTRIDGE NOT LOADED ON THE DEVICE; THE RELOAD WAS NOTED TO BE RIGHT SIDE FULLY FIRED, LEFT SIDE PARTIALLY FIRED 1/16. NO OBVIOUS DAMAGE TO THE CARTRIDGE DECK WAS NOTED, WHICH SUGGESTS THE CARTRIDGE, MAY NOT HAVE BEEN FIRED OVER A HARD OBJECT. UPON EVALUATION OF THE RELOAD, THE CARTRIDGE BODY, ONE PIECE SLED AND SOME DRIVERS WERE NOTED TO BE DAMAGED. IN ORDER TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS OF THE RELOAD IT WAS DISASSEMBLED AND THE RELOAD WAS NOTED TO HAVE THE DECK, DRIVERS AND ONE PIECE SLED DAMAGED. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD AND IT 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. AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. VIDEO PROVIDED WAS REVIEWED DURING THE ANALYSIS OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, ALL STAPLES OF THE ANTERIOR WALL WERE NOT DEPLOYED AT THE SECOND FIRING BETWEEN THE STOMACH AND THE JEJUNUM THOUGH THE STAPLES OF THE POSTERIOR WALL WERE DEPLOYED AND FORMED PROPERLY. THE CARTRIDGE JAW WAS INSERTED INTO THE GASTRIC SIDE AND THE ANVIL JAW WAS INSERTED INTO THE JEJUNUM SIDE. THE CARTRIDGE WAS BLUE. THEN, OOZING OCCURRED. AFTER THAT, A SMALL INCISION WAS CREATED AND SUTURE WAS PERFORMED TO COMPLETE THE CASE. THE AMOUNT OF OOZING WAS UNKNOWN. BLOOD TRANSFUSION WAS NOT REQUIRED. THE PATIENT IS STABLE AT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147152 POWERED ECHELON FLEX STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention