BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 17122239 · Received June 13, 2023

    Report

    Report Number
    2955842-2023-16283
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Date of Event
    May 19, 2023
    Report Date
    May 23, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110690
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE REPLACED LAMP MODULE TO PERFORM FAILURE ANALYSIS. THE LAMP MODULE WAS ANALYZED, AND FAILURE ANALYSIS INVESTIGATIONS DID NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE LAMP MODULE WAS INSTALLED ON AN IN-HOUSE SYSTEM. THE LAMP MODULE WAS RECOGNIZED WITH NO ISSUES. THE LAMP MODULE WAS POWERED ON, AT NO POINT DID THE LIGHT DIM OR TURN OFF. NO PRODUCT ISSUE WAS IDENTIFIED. FAILURE ANALYSIS ALSO FOUND AN OBSERVATION NOT REPORTED BY THE SITE AND NOT RELATED TO THE REPORTED ISSUE: THE LAMP MODULE WAS FOUND TO HAVE THERMAL DAMAGE ON ONE OF THE CONNECTIONS AS WELL AS THE HOUSING. ADVANCED FAILURE ANALYSIS FURTHER CONFIRMED THAT THE LAMP MODULE FUNCTIONED, AND NO ISSUES WERE OBSERVED WITH THE FUNCTIONALITY. THE THERMAL DAMAGE WAS OBSERVED AT ONE OF THE POWER CONNECTIONS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO MISHANDLING/MISUSE AND CAN BE CAUSED BY THE LAMP MODULE NOT BEING PROPERLY SEATED WITH THE ILLUMINATION MODULE. WHEN A CONNECTION IS NOT PROPERLY SEATED, ADDITIONAL RESISTANCE IS ADDED AT THE CONNECTION WHICH CAN HEAT UP WHEN CURRENT PASSES THROUGH THE CONNECTION. A REVIEW OF THE SUBMITTED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) REGULATORY POST MARKET SURVEILLANCE (RPMS) ANALYST. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE IMAGE OF THE LAMP MODULE IDENTIFIES THERMAL DAMAGE ON THE PORT THAT CONNECTS TO THE CABLE CONNECTOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY SURGICAL PROCEDURE, THE NURSE OBSERVED THAT THE OUTPUT OF THE LIGHT SOURCE DIMMED AND BECAME UNUSABLE SUSPECTING A DEFECTIVE LAMP MODULE. INFORMATION INDICATED THAT THE LAMP MODULE HAS USABLE LIFE REMAINING AND HAS NOT MET ITS END OF LIFE. THE USER COMPLETED THE PROCEDURE WITH NO OTHER ISSUE REPORTED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1972770 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-10 N/A 00886874110690

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES