BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** DEXTRUS* SEAL CAP

    MDR report key: 3090526 · Received May 2, 2013

    Report

    Report Number
    3005075853-2013-02112
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    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
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE IRIS SEAL OF THE DEVICE WAS TORN. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. HOWEVER, IT SHOULD BE NOTED THAT WITH THE IRIS SEAL TORN, THE OPENING AND CLOSING MECHANISM FUNCTIONED AS INTENDED. THE IRIS SEAL EXHIBITED A TEAR. THE INITIATION SITE FOR THE TEAR WAS ADJACENT TO THE INNER UPPER SEAL RING AND PROPAGATED DIAGONALLY TO THE LOWER RING, WHERE THE TEAR CONTINUED 360º AROUND THE LOWER RING. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEXTRUS SEAL WAS BROKEN WHEN THE SURGEON WAS USING IT. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193065 ENDOPATH** DEXTRUS* SEAL CAP LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA J4AT2P

    Patients

    Seq Age Sex Outcome Treatment
    1