BEUDAMED
    FDA Adverse Event Summary report: N

    DEXTRUS SEAL CAP ASSEMBLY

    MDR report key: 954655 · Received November 26, 2007

    Report

    Report Number
    3005075853-2007-00002
    Date Received
    November 26, 2007
    Date of Event
    October 30, 2007
    Report Date
    November 2, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GCJ
    PMA / PMN Number
    K070198
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVAL. HEADER CORRECTED DATA: ETHICON ENDO-SURGERY, INC = ETHICON ENDO-SURGERY, LLC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP SIGMOID PROCEDURE, THE TOP OF THE DEVICE RIPPED. THEY GOT A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE. NO RETURN DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS SEAL CAP ASSEMBLY GCJ ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR