BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES

    MDR report key: 1070572 · Received July 2, 2008

    Report

    Report Number
    3005075853-2008-00270
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 11, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HAND ASSISTED COLECTOMY PROCEDURE, THE DEVICE'S SEAL TORE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE PT CONSEQUENCE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1