BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* STABILITY SLEEVE

    MDR report key: 3091374 · Received May 3, 2013

    Report

    Report Number
    3005075853-2013-02105
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 9, 2013
    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
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF THE FOUND THAT THE DEVICE WAS RECEIVED WITH THE DUCKBILL OUT OF POSITION AND PRESENT. ONE POTENTIAL CAUSE FOR THE DAMAGE FOUND MAY BE THE SNAGGING OF AN INSTRUMENT DURING INSERTION. 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, PART OF THE DEVICE ENTERED INTO THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194885 ENDOPATH** XCEL* STABILITY SLEEVE LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA K4C25J

    Patients

    Seq Age Sex Outcome Treatment
    1