BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** DEXTRUS* SEAL CAP

    MDR report key: 3140334 · Received May 31, 2013

    Report

    Report Number
    3005075853-2013-02703
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE IRIS VALVE SEAL WAS BROKEN WHEN THE SURGEON REVOLVED THE UPPER SEAL RING. CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT ON THE PATIENT. PROCEDURE WAS PROLONGED BY FIVE MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242102 ENDOPATH** DEXTRUS* SEAL CAP LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1