BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* TROCAR

    MDR report key: 1984178 · Received February 10, 2011

    Report

    Report Number
    3005075853-2011-00565
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 13, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. THE ANALYSIS RESULTS FOUND THAT THE SLEEVE WITHOUT THE OBTURATOR WAS RECEIVED. UPON EVALUATION, THE TIP OF THE SLEEVE WAS NOTED TO BE DAMAGED. ONE POSSIBLE CAUSE FOR THIS TYPE OF DAMAGE MAY BE INTERACTION WITH AN ENERGIZED DEVICE USED DURING THE PROCEDURE. CAUTION SHOULD BE TAKEN TO AVOID CONTACT BETWEEN AN ENERGIZED DEVICE AND THE TROCAR DURING THE SURGICAL PROCEDURE; HOWEVER, THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED. AS THE OBTURATOR WAS NOT RECEIVED FOR EVALUATION NO TESTING COULD BE PERFORMED TO THE EVALUATED THE REPORT FRACTURED CLEAR LENS. AS THE OBTURATOR WAS NOT RECEIVED AND IT IS THE PART THAT HAS THE BATCH STAMPED, WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES. THE ANALYSIS RESULTS FOUND THAT THE SLEEVE WITHOUT THE OBTURATOR WAS RECEIVED. UPON EVALUATION, THE TIP OF THE SLEEVE WAS NOTE TO BE DAMAGED. ONE POSSIBLE CAUSE FOR THIS TYPE OF DAMAGE MAY BE INTERACTION WITH AN ENERGIZED DEVICE USED DURING THE PROCEDURE. CAUTION SHOULD BE TAKEN TO AVOID CONTACT BETWEEN AN ENERGIZED DEVICE AND THE TROCAR DURING THE SURGICAL PROCEDURE; HOWEVER, THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED. AS THE OBUTADOR WAS NOT RECEIVED FOR EVALUATION NO TESTING COULD BE PERFORMED TO THE EVALUATED THE REPORT FRACTURED CLEAR LENS. AS THE OBTURATOR WAS NOT RECEIVED AND IT IS THE PART THAT HAS THE BATCH STAMPED, WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROBOTIC HYSTERECTOMY PROCEDURE, A PIECE OF THE TROCAR CRACKED OFF THE TIP. IT IS UNKNOWN IF THE PIECE FELL INTO THE PATIENT. THE TIP OF A SECOND TROCAR USED IN THE PROCEDURE MAY HAVE BEEN BURNT. IT IS UNCLEAR. THE TROCARS WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1