BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES

    MDR report key: 1080527 · Received July 24, 2008

    Report

    Report Number
    3005075853-2008-00440
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Report Date
    June 17, 2008
    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
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICE TORE. THE CASE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES NONE GCJ ETHICON ENDO-SURGERY, LLC NA E4L377

    Patients

    Seq Age Sex Outcome Treatment
    1