BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSORB

    MDR report key: 2894837 · Received November 15, 2007

    Report

    Report Number
    3004028675-2007-00004
    Event Type
    Other
    Date Received
    November 15, 2007
    Date of Event
    October 1, 2007
    Report Date
    November 14, 2007
    Manufacturer
    INCISIVE SURGICAL, INC.
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE CLINICAL INFO SUGGESTS THE OUTCOME IS RELATED TO: HIGH TENSION, USER TRAINING, AND/OR STORAGE CONDITIONS. HOSPITAL WAS REMOVING INDIVIDUAL UNIT BOXES FROM THE PRIMARY BOX, WHICH HAS A MAXIMUM TEMPERATURE INDICATING "DOT", SO INTER-HOSPITAL SHIPMENTS FROM WAREHOUSE FACILITY IN TRUCKS MAY HAVE EXCEEDED THE MAXIMUM TEMPERATURE ON THE LABELING OF 122 F DEGREES. EXCEEDING THIS TEMPERATURE CAN RESULT IN A LOWER RELIABILITY OF THE STAPLE PLACEMENT MECHANISM. RETRAINING ON THE USER TECHNIQUE AND THE STORAGE CONDITIONS HAS ALREADY BEEN COMPLETED. ALL THE STOCK WAS UPDATED TO NEW INVENTORY OF MODEL 1025. ADD'L LOT NUMBER 072301.

    Description of Event or Problem · 1

    AN INCISION CLOSURE SEPARATED AT APPROX 10-12 HOURS POST-OP REQUIRING SURGICAL INTERVENTION FOR RE-CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSORB SKIN STAPLER GDW INCISIVE SURGICAL, INC. INSORB 20 072801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R