BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES

    MDR report key: 1271946 · Received December 29, 2008

    Report

    Report Number
    3005075853-2008-00094
    Event Type
    Malfunction
    Date Received
    December 29, 2008
    Date of Event
    May 5, 2008
    Report Date
    May 8, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 05/21/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE SEAL CAP BROKE. ANOTHER LIKE DEVICE TO COMPLETE THE CASE. NO PT CONSEQUENCE WAS REPORTED.

    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 E4J99H

    Patients

    Seq Age Sex Outcome Treatment
    1