BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEX 60 ENDO

    MDR report key: 2250603 · Received September 16, 2011

    Report

    Report Number
    3005075853-2011-03822
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 24, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE LTS60A DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH TWO RELOADS PRESENT. THE RELOADS WERE RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED AND CUT WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC RECTO SIGMOID RESECTION PROCEDURE, THE SURGEON STATED THAT; AFTER LOW-ANTERIOR RESECTION, THE PATIENT WAS PREPARED FOR END-TO-SIDE ANASTOMOSIS. HOWEVER; AFTER CEA CIRCULAR STAPLING, THE DOCTOR OBSERVED A FECES LEAK FROM THE ANASTOMOSIS LINE. AS A RESULT OF A RECTAL EXAMINATION, THE CIRCULAR STAPLE LINE WAS FOUND TO BE IN GOOD CONDITION (STRONG AND STABLE), BUT A DEFECT WAS OBSERVED IN THE AREA OF THE LINEAR CUTTER AND STAPLER. THE PATIENT WAS GIVEN A TEMPORARY COLOSTOMY BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEX 60 ENDO STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK E4K207

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4)