BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* BLADELESS TROCAR

    MDR report key: 2113680 · Received June 3, 2011

    Report

    Report Number
    3005075853-2011-02282
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD CONDITION. UPON EVALUATION, NO FOREIGN MATTER OR BROKEN/MISSING COMPONENTS WERE NOTED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. 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 AN UNKNOWN PROCEDURE, WHILE REMOVING THE TROCAR FROM THE PATIENT, THEY NOTICED SOME ORANGE PARTICLES COMING OFF THE CANNULA. THE PIECES WERE COMING FROM THE RIDGE OF THE STABILITY SLEEVE. SOME OF THE PARTICLES WERE REMOVED FROM THE PATIENT. THEY ARE UNSURE IF ALL THE PARTICLES WERE REMOVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1