BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DILATING TIP TROCAR

    MDR report key: 82080 · Received February 25, 1997

    Report

    Report Number
    9680598-1997-00028
    Event Type
    Malfunction
    Date Received
    February 25, 1997
    Date of Event
    January 27, 1997
    Report Date
    February 24, 1997
    Manufacturer
    EES-JUAREZ
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF EVALUATION: CONCLUSION: BASED ON THE VISUAL EXAMINATION AND THE FUNCTIONAL TESTING; THE INSTRUMENT FUNCTIONED AS INTENDED.

    Description of Event or Problem · 1

    DURING A DIAGNOSTIC LAPAROSCOPIC PROCEDURE THE ACTIVATION BUTTON ON THE 511SD WOULD NOT STAY ARMED DURING INSERTION. ANOTHER TROCAR WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT. CLINICAL FOLLOW UP: 1/29/97 1358 MESSAGE AND 800# LEFT FOR MD CALL BACK. 1/31/97 NNCL SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH DILATING TIP TROCAR TROCAR GCJ EES-JUAREZ NA K45T9L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other