BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 17367882 · Received July 20, 2023

    Report

    Report Number
    2955842-2023-17208
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    June 22, 2023
    Report Date
    June 22, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ARM 4 ROTATING BY ITSELF, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE WAS UNABLE TO REPRODUCE THE REPORTED ISSUE. NO PARTS WERE REPLACED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS NOT CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE DID NOT CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, ARM 4 WAS ROTATING BY ITSELF ONCE THE CANNULA AND INSTRUMENT WERE INSTALLED. THE ISSUE OCCURRED TWO TIMES AFTER REMOVING AND REINSTALLING ONE INSTRUMENT. THE TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE CUSTOMER TO KEEP INSTRUMENT ONCE SURGERY WAS DONE, TO GUIDE THEM TO EMERGENCY POWER OFF (EPO) THE PATIENT SIDE CART (PSC). TSE HARD POWER CYCLE PSC WITH AND NO ERROR AT THE NEXT POWER UP SEQUENCE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE ARM ROTATED ON ITS OWN WHEN THE SURGEON TOOK CONTROL OF THE SURGEON'S CONSOLE. ACCORDING TO THE CUSTOMER, IT WAS POSSIBLY RELATED TO ARM POSITIONING. THE REPORTER DOES NOT REMEMBER WHICH INSTRUMENT WAS INSTALLED ON THE ARM. IT WAS NOT AN INSTRUMENT ISSUE. THE INSTRUMENT WORKED ON THE OTHER ARMS. THE ROTATION ISSUE OCCURRED WHILE THE SURGEON'S HEAD WAS INSIDE THE HIGH-RESOLUTION STEREO VIEWER ON THE SURGEON'S CONSOLE. THE ISSUE OCCURRED WHILE THE SURGEON WAS TRYING TO MANIPULATE INSTRUMENTS FROM THE SURGEON'S CONSOLE. NO SHAKINESS AND/OR FRICTION WAS OBSERVED. THERE WAS NO INTERFERENCE BETWEEN THE INSTRUMENTS OR BETWEEN THE ARMS OF THE SYSTEM. THERE WERE NO EXTERNAL COLLISIONS. THE REPORTED ISSUE WAS INTERMITTENT. THE INSTRUMENT ARM DRAPE HAS BEEN THROWN AWAY. THE OPERATION WAS CONVERTED, AS 1 ARM WAS NOT USABLE, AND ONE EYE OF THE OPTICS WAS DEFECTIVE. THE CONVERSION DID NOT RESULT IN AN INCREASE IN THE SIZE OF THE INCISION OR ADDITIONAL PORTS. THE PATIENT DID TOLERATE THE CONVERSION. THERE WAS NO PATIENT HARM NOR INJURY. ISI ALSO FOLLOWED UP WITH THE FIELD SERVICE ENGINEER (FSE) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE OCCURRED BECAUSE THE POSITIONING OF THE ARM/TROCAR WAS INCORRECT. MORE PRECISELY, THE TROCAR WAS INCORRECTLY POSITIONED. THE ARM WAS NOT DEFECTIVE AND THEREFORE HAS NOT BEEN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369826 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-05 N/A

    Patients

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