BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* TROCAR

    MDR report key: 2050916 · Received April 12, 2011

    Report

    Report Number
    3005075853-2011-01461
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Report Date
    March 23, 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
    AZ, US
    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 A LAPAROSCOPIC CHOLECYSTECTOMY OR HERNIA REPAIR PROCEDURE ON A LARGE PATIENT, THE TROCAR BROKE IN HALF. PIECES FELL INTO THE PATIENT AND WERE RETRIEVED THROUGH AN AUXILIARY PORT ALREADY PLACED. THE EVENT OCCURRED AT THE END OF THE PROCEDURE. THERE WAS NO NEED TO OPEN A NEW DEVICE. THERE WAS NO PATIENT IMPACT REPORTED. THE DEVICE WAS DISCARDED.

    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