BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH*XCEL

    MDR report key: 1902627 · Received November 18, 2010

    Report

    Report Number
    3005075853-2010-06589
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 26, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNED. THE PRODUCT INVOLVED IN THIS EVENT WAS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE WOULD NOT INSUFFLATE. AN IMPORTANT GAS LEAKAGE WAS NOTICED DURING USE OF THE DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 1

    A SURGEON REPORTED RECEIVING A SYSTEM MESSAGE DURING A PROCEDURE. THE SYSTEM WAS SWITCHED OUT AND THE CASE WAS COMPLETED. THE SURGERY WAS DELAYED FOR APPROX 15 MINUTES. ADDITIONAL INFORMATION WAS REC'D FROM THE SURGEON REPORTING THE PT HAD CORNEAL EDEMA DURING SURGERY AND THE FOLLOWING DAY. THE SURGEON FEELS THE EDEMA WILL REGRESS WITH TIME. A SAMPLE WILL BE RETURNED FOR IN-HOUSE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH*XCEL LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. G4T021

    Patients

    Seq Age Sex Outcome Treatment
    1