BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL BLUNT TIP TROCAR

    MDR report key: 1830352 · Received January 10, 2008

    Report

    Report Number
    1527736-2008-00202
    Event Type
    Malfunction
    Date Received
    January 10, 2008
    Date of Event
    December 27, 2007
    Report Date
    December 28, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE, THE DEVICE LEAKED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH XCEL BLUNT TIP TROCAR GCJ ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4H60X

    Patients

    Seq Age Sex Outcome Treatment
    1