BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES

    MDR report key: 1001311 · Received February 19, 2008

    Report

    Report Number
    3005075853-2008-00021
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 24, 2008
    Report Date
    January 25, 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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLECTOMY, THE DEVICE SEAL ASSEMBLY WILL NOT HOLD AND THE DEVICE WOULD NOT STAY RATCHETED DOWN. THE SEAL RIPPED AFTER HOLDING WITH BABCOCKS. THE DEVICE WAS REMOVED AND CONTINUED THE CASE WITH NO PATIENT 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 D4JR74

    Patients

    Seq Age Sex Outcome Treatment
    1