BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* DILATING TIP TROCAR

    MDR report key: 2111741 · Received June 2, 2011

    Report

    Report Number
    3005075853-2011-02245
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 7, 2011
    Report Date
    May 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. THE ANALYSIS RESULTS FOUND THAT THE INSTRUMENT WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON CUTTING THE SKIN TEST MEDIA, THE RESET BUTTON REMAINED IN ARMED POSITION; HOWEVER, THE BULLET COULD NOT BE RETRACTED TO EXPOSE THE KNIFE. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THIS CONDITION. 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 AN UNKNOWN PROCEDURE, MECHANISM DID NOT DEPLOY TO PREVENT BLADE EXPOSURE. THE CONDITION OF THE PATIENT IMMEDIATELY AFTER THE PROCEDURE WAS STABLE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** XCEL* DILATING TIP TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA H4312N

    Patients

    Seq Age Sex Outcome Treatment
    1