BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DILATING TIP TROCAR

    MDR report key: 154774 · Received March 5, 1998

    Report

    Report Number
    1527736-1998-00645
    Event Type
    Malfunction
    Date Received
    March 5, 1998
    Date of Event
    February 2, 1998
    Report Date
    February 6, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING #.49306. EES #.980864/J. ENDOPATH DILATING TIP TROCAR: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONFIRMED THAT THE REPORTED EVENT OCCURRED. THE SLEEVE WAS RECEIVED WITH THE INNER GASKET DISLODGED FROM ITS ORIGINAL POSITION. THE INNER GASKET WAS RECEIVED IN A SEPARATE SEALED POUCH, COMPLETE. NO CONCLUSION COULD BE REACHED AS TO HOW THE INNER GASKET HAD BECOME DISLODGED FROM ITS ORIGINAL POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE 512D WAS USED DURING AN UNK PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THE INNER GASKET FELL INTO THE PT AND WAS RETRIEVED. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH DILATING TIP TROCAR TROCAR GCJ ETHICON ENDO-SURGERY, INC. NA K48J2F

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other