BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES

    MDR report key: 1080445 · Received July 24, 2008

    Report

    Report Number
    3005075853-2008-00404
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 18, 2008
    Report Date
    June 20, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 07/11/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HAND ASSISTED RIGHT COLON PROCEDURE, THE DEVICE RIPPED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1