BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** DEXTRUS* SEAL CAP

    MDR report key: 3223804 · Received July 12, 2013

    Report

    Report Number
    3005075853-2013-03536
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 27, 2013
    Report Date
    July 4, 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
    CA
    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 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 LOWER INNER SEAL RING, AND THEN IT PROPAGATED AROUND THE UPPER SEAL RING. HOWEVER, IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THIS CONDITION. A BATCH/LOT RECORD REVIEW WAS PERFORMED AND THE BATCH MET ALL FINAL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SEAL OF THE DEVICE TORE APART WHEN THE SURGEON WAS INSERTING HAND THROUGH THE OPENING. PROCEDURE COMPLETED WITH SAME/LIKE DEVICE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321391 ENDOPATH** DEXTRUS* SEAL CAP LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA K4CD9L

    Patients

    Seq Age Sex Outcome Treatment
    1