BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* TROCAR

    MDR report key: 2133799 · Received June 20, 2011

    Report

    Report Number
    3005075853-2011-02497
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 26, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF THE FOUND THAT THE DEVICE WAS RECEIVED WITH THE OBTURATOR CANNULA BENT. THEREFORE, THE SCOPE WOULD NOT FIT THROUGH THE CANNULA. A POTENTIAL CAUSE OF THIS DAMAGE IS THE APPLICATION OF AN EXCESSIVE FORCE ON THE OBTURATOR OVER THE SLEEVE ASSEMBLY AREA THAT CAUSES THE OBTURATOR TO BECOME BENT DURING TRANSIT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPY PROCEDURE, THE SCOPE WILL NOT PASS THROUGH THE TROCAR; THE TROCAR HAS A DENT IN THE SHAFT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    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 H43DOL

    Patients

    Seq Age Sex Outcome Treatment
    1 SCOPE