BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH DISPOSABLE SURGICAL TROCAR

    MDR report key: 224632 · Received May 24, 1999

    Report

    Report Number
    1527736-1999-03079
    Event Type
    Injury
    Date Received
    May 24, 1999
    Date of Event
    April 30, 1999
    Report Date
    April 30, 1999
    Manufacturer
    ETHICON ENDO-SURGERY, INC. S.A. DE C.V.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (1) DEVICE WAS USED DURING A LAPAROSCOPIC CYSTECTOMY. IT WAS REPORTED BY THE AFFILIATE THAT THE 512X TROCAR WAS BEING USED AS A CAMERA PORT DURING THE PROCEDURE. AT THE END OF THE PROCEDURE, IT WAS NOTICED THAT THE TROCAR CANNULA END WAS BROKEN, WHEN PULLING THE SCOPE OUT OF THE TROCAR PORT. THE PATIENT HAD TO BE OPENED UP (CONVERT TO OPEN) TO RETRIEVE THE BROKEN PIECES. NOT ALL OF THE PIECES WERE RETRIEVED. THEY WERE UNABLE TO DO AN MRI, SINCE THE TROCAR IS RADIOLUCENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH DISPOSABLE SURGICAL TROCAR TROCARS GCJ ETHICON ENDO-SURGERY, INC. S.A. DE C.V. NA J41W2W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention