BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY SPATULA INSTRUMENT

    MDR report key: 3924425 · Received July 9, 2014

    Report

    Report Number
    2955842-2014-04194
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 13, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND CONDUCTOR WIRE DISLODGED AT THE CONDUCTOR CAP. THE CONDUCTOR WIRE WAS NOT DAMAGED AND ELECTRICAL CONTINUITY TEST WAS PERFORMED AND PASSED. ADDITIONAL OBSERVATION NOT REPORTED WAS THE EARS OF THE PROXIMAL CLEVIS WERE BROKEN AND MISSING MATERIAL. FAILURE ANALYSIS CONCLUDED THAT THE DAMAGE WAS LIKELY DUE TO MISHANDLING. NO OTHER DAMAGE WAS FOUND. THE ENDOWRIST® INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE MISSING MATERIAL FROM THE BROKEN EARS OF PROXIMAL CLEVIS FOUND DURING FAILURE ANALYSIS COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SURGICAL PROCEDURE, THE CABLE ON THE PERMANENT CAUTERY SPATULA INSTRUMENT WAS DISENGAGED. THERE WAS NO ALLEGATION OF HARM OR INJURY TO A PATIENT. NOTHING REPORTEDLY FELL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401963 PERMANENT CAUTERY SPATULA INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420184-06 M10140217 415

    Patients

    Seq Age Sex Outcome Treatment
    1