BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 16971424 · Received May 21, 2023

    Report

    Report Number
    2955842-2023-14042
    Event Type
    Malfunction
    Date Received
    May 21, 2023
    Date of Event
    December 8, 2020
    Report Date
    December 8, 2020
    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
    VA, 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 FSE WENT ONSITE TO TROUBLESHOOT THE ISSUE THE DAY THE PROBLEM WAS REPORTED. THE FSE DISCOVERED SEVERAL CODE 22008 CANNULA ISSUES IN THE SYSTEM LOGS FOR THE PATIENT SIDE MANIPULATOR (PSM) 2, AND WAS ABLE TO REPRODUCE THE ISSUE ON THE TEST DRIVE; BUT, UPON A HARD CYCLE REBOOT THE ISSUE WENT AWAY. THE SAME ISSUE WAS ALSO INTERMITTENTLY OCCURRING ON THE PSM 1. THE FSE REPLACED THE CANNULA MOUNTS ON THE PSM 1 AND PSM 2. THIS RESOLVED THE ISSUE ON THE PSM 1; BUT, PSM 2 WAS STILL HAVING THE PROBLEMS. ROBOTICS COORDINATOR (ROCO) SAID THEY WOULD USE THE SYSTEM WITH THE PSM 3 AND PSM 1, UNTIL THE PSM 2 COULD BE REPLACED. THE FSE REPLACED THE PSM 2, TESTED THE SYSTEM, AND WAS ABLE TO SUCCESSFULLY INSERT INSTRUMENTS MULTIPLE TIMES. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE PARTS INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION WAS ABLE TO REPRODUCE THE CUSTOMER REPORTED COMPLAINT. THE STERILE ADAPTER (SA) RELEASE ASSEMBLY WILL BE REPLACED AS A FIX.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE SYSTEM'S PATIENT SIDE MANIPULATOR (PSM) 2 WAS HAVING INTERMITTENT ISSUES ACCEPTING INSTRUMENTS. THE SITE WAS USING AN INSTRUMENT ON THE PSM 2 WITH NO ISSUES, BUT WHEN THEY WENT TO PUT A SECOND INSTRUMENT ON THE ARM, THEY COULD NOT CONTROL THE INSTRUMENT. THE SITE RESEATED THE DRAPE, BUT THE ISSUE PERSISTED. THE SITE CONTINUED THE PROCEDURE WITH THE PSM 3. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED PATIENT HARM, INJURY, OR ADVERSE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741642 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-11 N/A 00886874110690

    Patients

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