BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIPATH FLEXIBLE SURGICAL TROCAR

    MDR report key: 1020389 · Received February 29, 2008

    Report

    Report Number
    1527736-2008-01272
    Event Type
    Injury
    Date Received
    February 29, 2008
    Report Date
    February 19, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GCJ
    PMA / PMN Number
    K931111
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE DEVICE, IT WAS INADVERTENTLY PUSHED INTO THE PUNCTURE WOUND INCISION. AT THE TIME NO ONE NOTICED IT. THE PATIENT RETURNED SOME WEEKS LATER WITH AN INFECTION. DURING ANOTHER PROCEDURE, THE PRODUCT WAS DISCOVERED AND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIPATH FLEXIBLE SURGICAL TROCAR GCJ ETHICON ENDO SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1