BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DISPOSABLE SURGICAL TROCAR

    MDR report key: 82050 · Received February 27, 1997

    Report

    Report Number
    9680598-1997-00033
    Event Type
    Malfunction
    Date Received
    February 27, 1997
    Date of Event
    January 24, 1997
    Report Date
    February 26, 1997
    Manufacturer
    EES-JUAREZ
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF EVALUATION: CONCLUSION: BASED IN THE VISUAL EXAMINATION AND THE FUNCTIONALITY TESTING THE INSTRUMENT WAS FOUND TO FUNCTION AS INTENDED. NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT WOULD NOT ARM.

    Description of Event or Problem · 1

    DURING A DIAGNOSTIC LAPAROSCOPY THE TROCAR BLADE WOULD NOT ACTIVATE. A SECOND DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT. CLINICAL FOLLOW-UP: 1/31/97 1420 MESSAGE AND 800 # LEFT FOR SURGEON TO CALL BACK. 2/3/97 1825 NNCL SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH DISPOSABLE SURGICAL TROCAR TROCAR GCJ EES-JUAREZ NA J4599U

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other