BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 10633207 · Received October 6, 2020

    Report

    Report Number
    2955842-2020-11044
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Date of Event
    September 11, 2020
    Report Date
    September 11, 2020
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    4307- INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MASTER TOOL MANIPULATOR (MTML) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE CUSTOMER REPORTED COMPLAINT WAS REPRODUCED DURING SINE CYCLE. THE FOLLOWING PARTS WILL BE REPLACED AS A FIX: ESMB PCA, ESMP PCA, BLACK AND WHITE FFC'S, SLIP RING ASSAY, SLIP RING BOARD, MAIN WIRE HARNESS, ESMY PCA, RJS PCA, RJP PCA, GIMBAL BLACK FFC, GIMBAL WHITE FFC. ADDITIONAL FINDINGS FOUND DURING EVALUATION: ERROR 25520 WAS OBSERVED DURING EVALUATION. THE MJB PCA WILL BE REPLACED. BECAUSE THE GIMBAL HANDLE IS BEING REPLACED, THE ESMH PCA WILL ALSO BE REPLACED TO ACCOMMODATE THE REPAIR. DURING EVALUATION, THE OPTO BUTTON PADS WERE FOUND TO BE WORN OUT. THE OPTO BUTTON PADS WILL BE REPLACED. PHYSICAL DAMAGE TO THE GIMBAL GRIP LEVERS WAS OBSERVED DURING EVALUATION. BOTH GRIP LEVERS WILL BE REPLACED. PHYSICAL DAMAGE TO THE GIMBAL HANDLE WAS OBSERVED DURING EVALUATION. THE GIMBAL HANDLE WILL BE REPLACED. DURING EVALUATION, THE INNER GRIP SPRING WITHIN THE GIMBAL HANDLE WAS FOUND TO BE BROKEN. THE INNER GRIP SPRING WILL BE REPLACED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE REPORTED COMPLAINT WAS REPRODUCED BASED ON THE FIELD EVALUATION. THE FSE REPLACED THE (MASTER TOOL MANIPULATOR-LEFT) AND THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. MTM REFERS TO THE MASTER CONTROLLERS WHICH PROVIDE THE MEANS FOR THE SURGEON TO CONTROL THE INSTRUMENTS AND ENDOSCOPE INSIDE THE PATIENT FROM THE SSC. ONE MTM IS ASSIGNED TO THE SURGEONS' LEFT HAND (MTML) AND ONE TO THE RIGHT (MTMR). ISI HAS NOT RECEIVED THE MTML INVOLVED WITH THIS COMPLAINT. THEREFORE, THE ROOT CAUSE OF THE ALLEGED CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE UNIT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE (FIRST PORT INCISION) CONTRIBUTED TO THE PROCEDURE BEING ABORTED. ALTHOUGH THERE WAS NO PATIENT INJURY REPORTED, IF THE REPORTED ISSUE WERE TO RECUR, IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE SYSTEM HAD NON RECOVERABLE ERROR 25521. THE TECHNICAL SERVICE ENGINEER REVIEWED THE ERROR 25521 REPORTED IN THE ERROR LOG. THE TSE INFORMED THE SURGEON THAT THE SYSTEM WAS DOWN AND TO MAKE AN ALTERNATE DECISION FOR PROCEEDING WITH THE SURGERY. THE PROCEDURE WAS ABORTED AND RE-SCHEDULED FOR THE FOLLOWING DAY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION. THE SYSTEM WAS INSPECTED PRIOR TO USE AND THERE WERE NO ISSUES WITH THE SYSTEM OR THE PORT PLACEMENTS. THE SURGICAL STAFF DID NOT OBSERVE ANY OUTSIDE INFLUENCES THAT WERE IMPEDING MOVEMENT OF THE SYSTEM OR PATIENT SIDE MANIPULATOR . THE CUSTOMER ATTEMPTED TO RESET THE INSTRUMENTS AND DRAPES. ALL TROUBLESHOOTING STEPS WERE EXHAUSTED WITH NO RESOLUTION TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102822 DAVINCI SI SURGEON SIDE CONSOLE NAY INTUITIVE SURGICAL, INC 380610-14 NA 00886874110683

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR DA VINCI INSTRUMENTS AND ACCESSORIES