BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL DILATING TIP TROCAR WITH STABILITY SLEEVE - 12 MM DIAMETER, 100 MM

    MDR report key: 932275 · Received October 24, 2007

    Report

    Report Number
    1527736-2007-06945
    Event Type
    Malfunction
    Date Received
    October 24, 2007
    Report Date
    October 17, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 10/23/2007. INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED LEAKAGE, COMPLETED WITH SAME LIKE PRODUCT, NO FURTHER INFO IS AVAILABLE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH XCEL DILATING TIP TROCAR WITH STABILITY SLEEVE - 12 MM DIAMETER, 100 MM GCJ ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR