BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* BLADELESS TROCAR

    MDR report key: 3217549 · Received July 10, 2013

    Report

    Report Number
    3005075853-2013-03511
    Event Type
    Malfunction
    Date Received
    July 10, 2013
    Date of Event
    June 12, 2013
    Report Date
    July 3, 2013
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: PLEASE PROVIDE THE MEDWATCH NUMBER FOR OUR REPORT. - TRIAGE UNIT 2013-005. DID THE SLEEVE OF THE TROCAR BREAK? YES, THE SLEEVE OF THE TROCAR BROKE. DID THE SURGEON CONVERT TO AN OPEN PROCEDURE TO REMOVE THE BROKEN PIECE FROM THE PATIENT? THE SURGEON DID NOT HAVE TO CONVERT TO AN OPEN PROCEDURE. THE BROKEN PIECE OF THE TROCAR WAS ABLE TO BE RETRIEVED THROUGH THE TROCAR INCISION. THE ANALYSIS RESULTS FOUND THAT THE INSTRUMENT WAS RECEIVED WITH THE SLEEVE BROKEN AND MELTED. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE ONE PRODUCED BY AN ENERGIZED DEVICE. IN ORDER TO PREVENT THIS KIND OF DAMAGE PLEASE AVOID THE CONTACT WITH LASER, ELECTROSURGICAL OR ULTRASONIC DEVICES. THE OBTURATOR WAS NOT RECEIVED FOR ANALYSIS. THE OBTURATOR IS THE PIECE OF THE TROCAR THAT HAS THE BATCH STAMPED. NO BATCH NUMBER WAS AVAILABLE; THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE.

    Description of Event or Problem · 1

    PER USER FACILITY MEDWATCH FORM, TRIAGE UNIT #NONE PROVIDED, DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY / BILATERAL SALPINGO OOPHORECTOMY PROCEDURE; THE DEVICE BROKE IN HALF WHEN THE PHYSICIAN PUT THE CAMERA BACK IN THE PATIENT AFTER DOING THE BELOW PART OF PROCEDURE. THE PHYSICIAN HAD TO GO IN AND RETRIEVE THE BROKEN PART OF THE DEVICE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318793 ENDOPATH** XCEL* BLADELESS TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA K4CC3Z

    Patients

    Seq Age Sex Outcome Treatment
    1