BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 16971822 · Received May 22, 2023

    Report

    Report Number
    2955842-2023-14305
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Date of Event
    June 17, 2020
    Report Date
    June 17, 2020
    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
    SD, 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 REPORTED COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION. THE FIELD SERVICE ENGINEER (FSE) USED TWO CAMERAS, TWO ENDOSCOPE, AND TWO CAMBER CABLES TO CONFIRM THE REPORTED ISSUES. IT WAS NOTED THE FSE FOUND THE FAULT WITH THE CAMERA CABLE AND ILLUMINATOR NOT FIRING UP THE LAMP PROPERLY. ERROR CODES 48244 ILLUMINATOR ERROR AND 48209 VIDEO LOCK LOST SCREEN WERE CONFIRMED. THE FSE REPLACED THE ILLUMINATOR (951183-06) AND CAMERA CABLE (371868-04) TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ILLUMINATOR INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION COULD NOT CONFIRM THE REPORTED COMPLAINT. A VISUAL INSPECTION WAS PERFORMED AND THE ILLUMINATOR WAS FOUND TO BEL IN GOOD CONDITION. THE ILLUMINATOR WAS INSTALLED AND TESTED ON THE PCA SYSTEM. NO ERRORS WERE OBSERVED DURING STARTUP. THE SYSTEM PERFORMED TEN POWER CYCLES AND NO TROUBLE WAS FOUND. IT WAS NOTED THE ILLUMINATOR PERFORMED THE FUNCTIONAL TEST WHICH WERE GOOD. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE CAMERA CABLE INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED THE REPORTED COMPLAINT. A VISUAL INSPECTION FOUND THE CAMERA CABLE HAD SOME DISCOLORATION. THE CAMERA CABLE WAS THEN INSTALLED INTO A PCA TEST SYSTEM AND FAILED WITH A BLACK/DARK IMAGE ON THE RIGHT EYE. THE CAMERA CABLE COULD NOT BE REPAIRED AND WAS SCRAPPED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER NOTED THE UPPER PORTION OF THE RIGHT EYE IN THE SURGEON SIDE CONSOLE (SSC) WAS BLACK. IT WAS NOTED THE CUSTOMER CALLED IN AFTER THE CASE COMPLETION. THE CUSTOMER INFORMED THE TECHNICAL SERVICE ENGINEER (TSE) THAT THEY TESTED THE SYSTEM BEFORE THE START OF THE CASE WITH NO ISSUES; HOWEVER, ONCE THE CAMERA WAS INSTALLED ON THE ARM, THE RIGHT EYE IN THE SSC GOT DARK. THE CUSTOMER STATED THEY REPLACED THE CAMERA HEAD AND TESTED THE SYSTEM AFTER THE CASE WITH NO ISSUES. THE TSE ASKED THE CUSTOMER IF THE ENDOSCOPE WAS INSTALLED DURING TESTING BEFORE AND AFTER THE CASE, AND THE CUSTOMER STATED THAT IT WAS. THE TSE ASKED THE CUSTOMER IF THE ISSUE WAS NOTICED ON THE VISION SIDE CART (VSC) TOUCHSCREEN, AND THE CUSTOMER STATED THEY DID NOT SWAP EYES ON THE VSC TO CONFIRM. IT WAS REQUESTED A FIELD SERVICE ENGINEER (FSE) FOLLOW UP AND INSPECT THE SYSTEM. THE TSE REVIEWED THE SYSTEM LOGS AND NOTICED MULTIPLE 48259 ERROR FOR THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) AND PERSONALITY MODULE VISION ACQUISITION (PMVA), WHICH COULD BE DUE TO A POSSIBLE BAD DIGITAL VIDEO INTERFACE (DVI) CABLE IF CONNECTED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507542 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-11 N/A

    Patients

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