BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SP

    MDR report key: 19056753 · Received April 6, 2024

    Report

    Report Number
    2955842-2024-13093
    Event Type
    Injury
    Date Received
    April 6, 2024
    Date of Event
    March 8, 2024
    Report Date
    March 8, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114605
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PATIENT SIDE MANIPULATOR (PSM) WAS ANALYZED AND REPORTED FAILURE WAS CONFIRMED. THE PSM WAS INSTALLED ONTO FA¿S SYSTEM AND STARTED UP IN NORMAL MODE WITHOUT TRIGGERING ANY FAULTS OR ERRORS. FA HAD ATTEMPTED TO INSTALL A STERILE ADAPTER, BUT THE PSM WOULD FAULT AND ASK TO REINSTALL THE SA. LOOKING IN THE SYSTEM LOGS, 41091 STERILE ADAPTER ENGAGEMENT ERRORS WERE SEEN. THE UNIT WAS THEN INSTALLED ONTO FA¿S PFTP WHERE IT FAILED ALL STERILE ADAPTER ENGAGEMENT RELATED TESTS ON AXIS 2/DOF3. THE PSM WAS DISASSEMBLED FOR INSPECTION OF THE SSFM AND SSFC PCA¿S, SA MOUNT, AND DOF 3 COMPONENTS BUT NO ABNORMALITIES COULD BE SEEN.

    Additional Manufacturer Narrative · 0

    A FIELD SERVICES ENGINEER (FSE) PERFORMED A SITE VISIT. THE ISSUE WAS REPRODUCED WHILE THE FSE ATTEMPTED TO SETUP PATIENT SURGICAL MANIPULATOR (PSM) 3 WITH A KNOWN GOOD STERILE ADAPTER AND EXPERIENCED THE SAME ISSUE AS THE CUSTOMER. THE FSE REPLACED PSM3 AND THE ROBOT THEN PASSED FULL SYSTEM OPERATIONAL TEST. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE PSM FOR EVALUATION, BUT THE TESTING IS STILL IN PROGRESS AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE CLINICAL SALES REPRESENTATIVE (CSR) CALLED IN TO REPORT DRAPE ISSUES WITH ARM 3. THE CSR STATED THAT WHEN THEY INSTALLED THE DRAPE, THE ENGAGEMENT STARTED THEN FAILED. THE SITE ATTEMPTED TO REPLACE THE DRAPE AND RESTART THE SYSTEM, BUT THE ISSUE REMAINED. THE TECHNICAL SUPPORT ENGINEER (TSE) VIEWED AND CONFIRMED 30900 ERRORS ON ARM 3 AND ADVISED THE CSR TO CHECK THE SENSORS ON THE ARM TO ENSURE BOTH WERE SPRING LOADED AND NOT DAMAGED. THE STAFF REMOVED THE DRAPE AND CONFIRMED ALL SENSORS LOOKED GOOD. THE TSE ASKED THE CSR IF A DIFFERENT DRAPE LOT NUMBER COULD BE LOCATED. THE CSR STATED THAT THE FIRST AND SECOND DRAPE WERE DIFFERENT LOT NUMBERS. THE TSE RECOMMENDED TO REMOVE THE STERILE ADAPTER, PUSH IN THE TWO STERILE ADAPTER PINS AND CHECK IF THE PASSED THE ENGAGEMENT PROCESS. THE STAFF PERFORMED THIS BUT WITH THE DRAPE REMOVED FROM THE ARM AND THE TWO PINS PRESSED, BUT THE ENGAGEMENT ERROR RETURNED. THE SITE ALSO ATTEMPTED TO INSTALL THE DRAPE AND INSTRUMENT, BUT THE ENGAGEMENT ERRORS REMAINED. THE TSE HAD THE CSR CONFIRM THE DRAPE WAS FULLY SEATED WITH NO INTERFERENCE. THE SITE ELECTED TO MOVE THE PROCEDURE TO THEIR XI SYSTEM. THE PROCEDURE WAS CONVERTED TO ANOTHER DA VINCI SYSTEM WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION BASED ON A FOLLOW-UP: THE CONVERSION WAS FROM SP RETROPERITONEAL PARTIAL NEPHRECTOMY TO XI TRANSABDOMINAL PARTIAL NEPHRECTOMY. THE PATIENT TOLERATED THE CHANGE AS THEY WERE ALREADY UNDER ANESTHESIA. THE ONLY ISSUE WAS THAT THE ARM DRIVE 3 FAILED TO REGISTER THE DRAPE OR ALLOW THE INSTRUMENT TO BE INSTALLED. THE SYSTEM WAS INSPECTED PRIOR TO USE WHERE THE CUSTOMER NOTICED THE DRAPE WAS NOT RECOGNIZED BY SYSTEM. CSR HAD NOTICED THE SAME THING PRIOR TO DEPLOYING FOR DOCKING. THE PROCEDURE WAS UNDERWAY. THEY HAD PLACED THE ACCESS PORT IN THE RETROPERITONEAL SPACE BEFORE THE DECISION WAS MADE TO WHEEL IN THE XI WHERE THE SURGEON HAD TO CHANGE THE APPROACH AND PORTS. THERE WERE NO POST-OPERATIONAL COMPLICATIONS. NO VIDEO RECORDING WAS AVAILABLE. NO PATIENT INFORMATION OR DEMOGRAPHICS WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084237 DA VINCI SP PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380601-44 N/A 00886874114605

    Patients

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