BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* TROCAR

    MDR report key: 2123595 · Received June 14, 2011

    Report

    Report Number
    3005075853-2011-02411
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE PHYSICIAN WAS USING THE MORCELLATOR, THE TIP OF THE TROCAR, A PIECE APPROXIMATELY 3MMX2MM WAS SHEARED OFF. ALL ATTEMPTS TO RETRIEVE THE PIECE OF TROCAR INCLUDING EXPLORATION AND IRRIGATION, HAVE NOT BEEN EFFECTIVE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    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 MORCELLATOR