BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 7672159 · Received July 9, 2018

    Report

    Report Number
    2955842-2018-10356
    Event Type
    Malfunction
    Date Received
    July 9, 2018
    Date of Event
    June 15, 2018
    Report Date
    June 15, 2018
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ISI HAS NOT RECEIVED THE MONOPOLAR CAUTERY INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION. THEREFORE, THE CUSTOMER REPORTED FAILURE HAS NOT BEEN DETERMINED. IF ADDITIONAL INFORMATION AND/OR THE INSTRUMENT IS RETURNED A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, ARCING WAS OBSERVED. ALTHOUGH, NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED AT THIS TIME IS UNKNOWN WHAT CAUSED THE ALLEGED ARCING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CAUTERY INSTRUMENT "IGNITED" AND A SPARK WAS NOTED AND WAS IMMEDIATELY REMOVED. THERE WAS NO REPORT OF FRAGMENTS FALLING INSIDE THE PATIENT DURING THE SURGICAL PROCEDURE AND NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY. ON 20-JUN-2018, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE INITIAL REPORTER: THE INITIAL REPORTER CONFIRMED THAT THE INSTRUMENT ARCED DURING THE PROCEDURE. THE INSTRUMENT IS CURRENTLY BEING HELD BY THE SITE'S RISK MANAGEMENT TEAM AND THE INITIAL REPORTER COULD NOT VERIFY IF IT WILL EVENTUALLY BE RETURNED TO ISI FOR FAILURE ANALYSIS. NO INJURY OR MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE ALLEGED ARCING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512876 DAVINCI SI MONOPOLAR CAUTERY NAY INTUITIVE SURGICAL, INC 420142

    Patients

    Seq Age Sex Outcome Treatment
    1