BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** DEXTRUS* SEAL CAP

    MDR report key: 2991509 · Received March 6, 2013

    Report

    Report Number
    3005075853-2013-01097
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 26, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TORN IRIS. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED WITH THE IRIS SEAL TORN. THE INITIATION SITE APPEARED TO BE ADJACENT TO THE O-RING AND MIGRATED APPROXIMATELY 270º AROUND ON THE UPPER INNER SEAL RING, AND THEN IT PROPAGATED TOWARD THE LOWER SEAL RING. HOWEVER, IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THIS CONDITION. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND 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 A LAPAROSCOPIC SIGMOID COLECTOMY PROCEDURE, THE SEAL TORE WHEN THE SURGEON WAS CLOSING THE DEVICE. A SECOND DEVICE WAS PULLED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96194 ENDOPATH** DEXTRUS* SEAL CAP LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA J4CK0W

    Patients

    Seq Age Sex Outcome Treatment
    1