BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL

    MDR report key: 1884505 · Received October 28, 2010

    Report

    Report Number
    3005075853-2010-06132
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. THE RETURNED PRODUCT HAS BEEN IDENTIFIED AS PART OF THE VOLUNTARY RECALL OF ENDOPATH XCEL 'WITH OPTIVIEW' TECHNOLOGY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE TROCAR WAS LEAKING INSUFFLATION AROUND THE SEAL. 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 LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA G4RV4D

    Patients

    Seq Age Sex Outcome Treatment
    1