BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCEL TROCAR 11MM

    MDR report key: 2123746 · Received June 14, 2011

    Report

    Report Number
    3005075853-2011-02418
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Report Date
    May 24, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 IN GOOD CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. DURING TESTING, THE RESET BUTTON WAS ARMED AND THE BLADE WAS EXPOSED AS INTENDED. UPON CUTTING THE SKIN TEST MEDIA, THE BULLET RECOVERED THE KNIFE AND THE RESET BUTTON RETURNED TO UNARMED POSITION; NO ANOMALIES WERE NOTED. THE DEVICE WAS FULLY FUNCTIONAL AND CONFORMING ACCORDING TO MANUFACTURING SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. 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 LAPAROSCOPIC GYNECOLOGICAL PROCEDURE, THE TWO PORTS WERE PLACED AND AFTER PLACEMENT THE BLADES FAILED TO RETRACT AUTOMATICALLY. NO ACTION NECESSARY. ONCE THEY HAD GAINED ENTRY THEY WERE ABLE TO REMOVE THE TROCAR AND JUST LEAVE THE SLEEVE IN PLACE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCEL TROCAR 11MM LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA H4333N

    Patients

    Seq Age Sex Outcome Treatment
    1