BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DILATING TIP TROCAR

    MDR report key: 159530 · Received March 24, 1998

    Report

    Report Number
    1527736-1998-00867
    Event Type
    Malfunction
    Date Received
    March 24, 1998
    Date of Event
    February 24, 1998
    Report Date
    February 24, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING #.49916. EES #.981373/J. D5,6; H4: INFO NOT AVAILABLE. ENDOPATH DILATING TIP TROCAR: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONFIRMED THAT THE REPORTED EVENT OCCURRED. NO CONCLUSION COULD BE REACHED AS TO HOW THE INNER GASKET HAD BECOME DISLODGED FROM ITS ORIGINAL POSITION OR HOW THE OUTER GASKETS WERE TORN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. IT WAS REPORTED THE GASKET FROM 511SD LOCATED AT THE SUBXYPHOID SITE FELL INTO THE PT'S ABDOMEN. THE GASKET WAS RETRIEVED LAPAROSCOPICALLY. THE PROCEDURE WAS COMPLETED WITH THE SAME TROCAR. THIS DEVICE CAME OUT OF AN FDC32 KIT. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other