BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 14234140 · Received April 28, 2022

    Report

    Report Number
    2955842-2022-11285
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    March 28, 2022
    Report Date
    March 28, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110683
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE REPLACED THE PMSC (PERSONALITY MODULE SURGEON CONSOLE). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS REQUESTED THE PMSC INVOLVED WITH THIS COMPLAINT BE RETURNED BUT THIS HAS NOT BEEN RECEIVED YET. THEREFORE, THE ROOT CAUSE OF THE ALLEGED CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE FAILURE ANALYSIS EVALUATION AND IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S COMPLAINT HISTORY FOUND NO ADDITIONAL COMPLAINTS RELATED TO THIS EVENT. NO IMAGE OR VIDEO WAS AVAILABLE FOR REVIEW. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY TECHNICAL SUPPORT WHEN THE CUSTOMER CALLED FOR TROUBLESHOOTING ASSISTANCE AND AN ERROR 48200 WAS FOUND TO BE RELATED TO THE COMPLAINT. THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER ABORTED PRIOR TO THE START OF THE PROCEDURE AFTER PORTS PLACEMENT DUE TO REPEATED RECOVERABLE ERRORS AND BLANK LEFT VISION IN THE SSC. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER FIRST PORT INCISION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A PROCEDURE CHANGE.BLANK MDR FIELD INFORMATION: FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: D9, G3, G6, H2, AND H3. EVALUATION INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: H6, AND H10. AN INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. IN-HOUSE FA FOUND THAT THE PRINTED CIRCUIT ASSEMBLY (PCA) WAS UNABLE TO INSTALL THE PMSC INTO SI TEST SYSTEM AS THE BOARDS WERE BURNT/OXIDIZES WHICH WAS CONFIRMED. THE PMSC COULD NOT BE REPAIRED, AND WAS THEREFORE SCRAPPED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START, POST ANESTHESIA, OF A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE LEFT VISION IN THE SURGEON SIDE CONSOLE (SSC) WAS BLANK AND THE SYSTEM RESTART DID NOT FIX THE ISSUE. THE TECHNICAL SERVICE ENGINEER (TSE) ASKED THE CUSTOMER TO REMOVE THE DVI CONNECTION IN THE SSC AND PERFORM HARD POWER CYCLE. THE CUSTOMER NOTED THAT THE SYSTEM HAD AN ERROR 48200 REPORTED AFTER EVERY POWER CYCLE. THE PROCEDURE WAS ABORTED POST ANESTHESIA AND POST PORT PLACEMENT WITH NO REPORT OF PATIENT INJURY. THE FIELD ENGINEER (FE) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION DURING THE SITE VISIT ON (B)(6) 2022: THE CUSTOMER NOTED ERROR 48200 WHEN THE SYSTEM INITIALLY TURNED ON. THE CUSTOMER RECOVERED THE ERROR WHICH DISABLED THE LEFT EYE. AFTER RECOVERING THE ERROR, THE CUSTOMER PROCEEDED WITH THE SYSTEM SETUP. THE SURGEON NOTED A BLANK LEFT EYE WHILE TAKING THE CONTROL OF THE SYSTEM. THE PATIENT WAS UNDER ANESTHESIA AND PORTS WERE PACED. TECHNICAL SUPPORT REVIEWED THE LOGS AND FOUND ERRORS ON THE PERSONALITY MODULE SURGEON CONSOLE (PMSC). THE PROCEDURE WAS ABORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON (B)(6) 2022: THE ISSUE WAS IDENTIFIED PRIOR TO STARTING, POST ANESTHESIA, OF THE PROCEDURE AND PORTS WERE PLACED. THE CUSTOMER DID NOT CHECK THE CONSOLE STEREO VIEWER STATUS. THE SYSTEM FUNCTIONALITY WAS NOT CHECKED UPON POWERING ON THE SYSTEM. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691247 DAVINCI SI SURGEON SIDE CONSOLE NAY INTUITIVE SURGICAL, INC 380610-14 N/A 00886874110683

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES.