BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL

    MDR report key: 1880663 · Received October 25, 2010

    Report

    Report Number
    3005075853-2010-06024
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 28, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED PRODUCT HAS BEEN IDENTIFIED AS PART OF THE VOLUNTARY RECALL OF ENDOPATH XCEL WITH OPTIVIEW TECHNOLOGY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE ARCHITECT CYCLOSPORINE REAGENT HAS GENERATED DISCREPANT RESULTS ON A PATIENT SAMPLE. THE RESULTS WERE REPEATEDLY <25.0 NMOL/L. THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND TESTED BY ANOTHER METHODOLOGY AND THE RESULT WAS 63 UG/L. THE ACCOUNT STATED THAT THE PATIENT WAS TREATED. FURTHER INFORMATION REGARDING WHAT TYPE OF TREATMENT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ESOPHAGECTOMY THE TROCAR WAS LOSING PNUEMO. THEY COMPLETED THE PROCEDURE WITH A NEW LIKE DEVICE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1