BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 14342983 · Received May 9, 2022

    Report

    Report Number
    2955842-2022-11548
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Date of Event
    April 11, 2022
    Report Date
    April 11, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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 REPRODUCED THE ISSUE OF NON-RESPONSIVE UNIVERSAL SIDE MANIPULATOR 2 (USM2). THE FSE REPLACED UNIVERSAL SIDE MANIPULATOR 2. AFTER REPLACEMENT, THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE USM INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE UNIT WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED PROBLEM WAS CONFIRMED THROUGH REVIEW OF THE LOGS IDENTIFYING RECOGNITION ISSUES THROUGH ERRORS 282 AND 31086. DURING INVESTIGATION, THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM AND PASSED NORMAL MODE. THE UNIT FAILED THE CARRIAGE SWITCHES TEST ON THE RFID. THE UNIT WENT THROUGH MORE TESTING AND PASSED DIRECTION TEST, LISSAJOUS RADIUS, CHIP ENCODER VIRTUAL ABSOLUTE (CVA) CHARACTERIZATION, SENSORS CHECK, SINE CYCLE, FRICTION TEST, CARRIAGE FRICTION TEST, BRAKE RELEASE TEST, BRAKE HOLD TEST, ADVANCED BRAKE TEST, AND CARRIAGE STRENGTH TEST. THE AXES CONTROLLER CARRIAGE RFID (ACCR) AND AXES CONTROLLER (CARRIAGE LOGIC) (ACCL) BOARDS WERE REPLACED ON USM2 TO ADDRESS THE REPORTED PROBLEM. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. THERE WAS NO IMAGE OR VIDEO CLIP SUBMITTED FOR REVIEW. SYSTEM LOG REVIEW: A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY TECHNICAL SUPPORT ENGINEER (TSE). INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: ERROR 31011 ¿ SYSTEM WAS UNABLE TO WRITE TO DALLAS CHIP ON TOOL ON USM2. ERROR 282 ¿ ONE OR MORE TOOL SENSORS WERE NOT DETECTED: TOOL SN WAS NOT AVAILABLE ON USM2 ERROR 31009 ¿ A TOOL WAS FULLY DETECTED, AND THEN ONE OR MORE (BUT NOT ALL) OF THE TOOL SENSORS WERE NOT DETECTED FOR 3 SECONDS ON USM2. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: A USM WAS DISABLED AFTER THE START OF THE PROCEDURE AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY USING 3 ARMS. 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 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 BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE UNIVERSAL SIDE MANIPULATOR 2 (USM2) WAS NON-RESPONSIVE. CUSTOMER RESEATED THE DRAPE WITH NO CHANGE. CUSTOMER DID NOT REPLACE THE DRAPE ON USM2 AND ELECTED TO PROCEED WITH THE CASE USING THE THREE REMAINING USM¿S. TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED LOGS AND NOTED A NUMBER OF ERRORS POINTING TO A POSSIBLE STERILE ADAPTER ISSUE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. 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
    2243763 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-31 00886874110720

    Patients

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