BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** DEXTRUS* SEAL CAP

    MDR report key: 3133021 · Received May 29, 2013

    Report

    Report Number
    3005075853-2013-02608
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 3, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HAND ASSISTED LAPAROSCOPIC COLECTOMY PROCEDURE, THE SEAL CAP TORE DURING THE HAND EXCHANGE. THERE WERE NO PATIENT CONSEQUENCES. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237114 ENDOPATH** DEXTRUS* SEAL CAP LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1