BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL*

    MDR report key: 1904527 · Received November 22, 2010

    Report

    Report Number
    3005075853-2010-06624
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 28, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED WITH THE RESET BUTTON IN SAFE POSITION AND WITH THE KNIFE COVERED. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. DURING FUNCTIONAL TESTING, THE RESET BUTTON WAS ARMED AS INTENDED; THE BULLET RETURNED TO THE ORIGINAL POSITION UPON CUTTING AND ADVANCING THROUGH THE SKIN TEST MEDIA. THE DEVICE WAS FULLY FUNCTIONAL AND CONFORMING ACCORDING TO OUR 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE HEALTHCARE PROFESSIONAL HAD DIFFICULTY REMOVING THE GUIDEWIRE OUT OF THE TWO CATHETERS. AFTER THE GUIDEWIRE WAS REMOVED IT WAS NOTED THAT BOTH CATHETERS HAD A LEAK IN THE MIDDLE. THE TWO CATHETERS WERE USED TO BUILD ONE CATHETER WHICH WAS IMPLANTED SUCCESSFULLY. THE DRUG USED WAS BACLOFEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY THE DEVICE BLADE WOULD NOT ENGAGE INTEROPERATIVELY. THEY COMPLETED THE PROCEDURE WITH A NEW LIKE DEVICE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THERE WAS NO OTHER INFORMATION AVAILABLE REGARDING THE EVENT AS THE DEVICE WAS LEFT IN THE MATERIALS DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** XCEL* LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1