BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 13835654 · Received March 20, 2022

    Report

    Report Number
    2955842-2022-10702
    Event Type
    Malfunction
    Date Received
    March 20, 2022
    Date of Event
    February 18, 2022
    Report Date
    February 18, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110874
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FIELD SERVICE ENGINEER (FSE) FOUND A RECURRING FAULT 297 AFTER CHANGING THE BULB AND WAS ABLE TO REPLICATE THE FAULT. THE FSE REPLACED THE ILLUMINATOR. THE NEW ILLUMINATOR WAS TESTED AND VERIFIED AS READY FOR USE. THE ILLUMINATOR HAS BEEN RETURNED AND EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM. FA REPLICATED AND CONFIRMED THE REPORTED ISSUE. THE ILLUMINATOR WAS INSTALLED ON AN IN-HOUSE SYSTEM AND IT FAILED TO POWER UP. IT SHOWED 297 AND 48238 ERRORS, WHICH INDICATE A COMMUNICATION FAILURE. UPON VISUAL INSPECTION, FAILURE ANALYSIS FOUND A BAD FUSE, NO LAMP MODULE, AND DUSTY FANS INSIDE THE UNIT. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY RELATED OR DUPLICATE COMPLAINTS INVOLVING THIS PRODUCT AND/OR THIS EVENT. A REVIEW OF THE LOGS CONFIRMED THE EVENT DATE WAS (B)(6) 2022 AND THE PROCEDURE WAS A PARTIAL NEPHRECTOMY. THE SYSTEM SERIAL NUMBER WAS CONFIRMED TO BE (B)(4). THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE ILLUMINATOR WAS REPLACED AFTER THE START OF THE PROCEDURE AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY WITH A BACKUP LIGHT SOURCE. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED AND MAY LEAD TO AN INJURY DUE TO THE PATIENT'S INABILITY TO TOLERATE A CONVERSION/ABORTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE ILLUMINATOR TURNED OFF DURING USE. THE TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND FOUND ERROR 48238 POINTING TO THE ILLUMINATOR. THE STAFF CONFIRMED THAT THE POWER AND CONNECTIONS ON THE ILLUMINATOR WERE GOOD. THE STAFF DID NOT HAVE AN EXTRA ILLUMINATOR BULB. THE TSE INSTRUCTED THE STAFF TO PROCURE AN EXTERNAL LIGHT SOURCE AND PLUG THE ILLUMINATOR CABLE INTO IT. THE STAFF WAS ABLE TO GET THE EXTERNAL LIGHT SOURCE TO TURN ON AND PROCEEDED WITH THE PROCEDURE USING THE EXTERNAL LIGHT SOURCE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) COMPLETED CUSTOMER FOLLOW-UP AND OBTAINED THE FOLLOWING INFORMATION: THE INITIAL REPORTER CONFIRMED THAT THE SITE COMPLETED THE PROCEDURE USING THE EXTERNAL LIGHT SOURCE, AND THERE WAS NO PATIENT INJURY. THE ISSUE WAS FIRST IDENTIFIED DURING THE PROCEDURE WHEN THE ILLUMINATOR TURNED OFF AFTER INITIALLY HAVING POWERED ON WITHOUT ERRORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651084 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-09 N/A 00886874110874

    Patients

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