BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 16075784 · Received December 29, 2022

    Report

    Report Number
    2955842-2022-16198
    Event Type
    Malfunction
    Date Received
    December 29, 2022
    Date of Event
    November 22, 2022
    Report Date
    December 1, 2022
    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
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE PATIENT SIDE MANIPULATOR (PN: 380900-01 SN:(B)(6)) WAS ANALYZED AND THE ISSUE WAS REPLICATED AND CONFIRMED THE REPORTED ISSUE. THE REPORTED ISSUE FAILED THE FRICTION TEST VIA MATLAB. THE L6 UPPER PULLEY WILL BE REPLACED TO FIX THE ISSUE. THE PATIENT SIDE MANIPULATOR (PN: 3880900-10 SN: (B)(6)) WAS ANALYZED AND FOUND TO FAILURE ANALYSIS INVESTIGATIONS WAS ABLE TO REPLICATE THE REPORTED EVENT. FAILURE ANALYSIS REPRODUCED THE ISSUE DURING CHECK SENSORS VIA MATLAB. THE SPRING PLUNGER WILL BE REPLACED AS A FIX.

    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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE FSE WAS ABLE TO REPRODUCE THE REPORTED ISSUE. THE FSE REPLACED THE PATIENT SIDE MANIPULATOR (PSM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER AND THE PATIENT SIDE MANIPULATORS (PSMS) WERE RECEIVED FOR EVALUATION. HOWEVER, THE FAILURE ANALYSIS TO CONFIRM/IDENTIFY ANY REPORTABLE FAILURE MODE(S) HAS NOT YET BEEN COMPLETED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED POST-EVALUATION AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. A PROCEDURE LOG REVIEW WAS PERFORMED. PER THE REVIEW, THE FOLLOWING WAS CONFIRMED: A UNILATERAL INGUINAL HERNIA PROCEDURE WAS PERFORMED ON SYSTEM (B)(4) ON (B)(6) 2022. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED TO ISI FOR REVIEW. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE INSTRUMENT STUCK ON THE ARM AND HAD TO BE PRIED OFF. FURTHERMORE, COMPLAINT INVESTIGATION CONFIRMED THE PSM WAS REPLACED TO RESOLVE THE ISSUE. 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 THE 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

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) WAS STUCK ON THE ARM. AN INTUITIVE SURGICAL INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CALLED THE ISI TECHNICAL SUPPORT ENGINEER (TSE), WHO VERIFIED THAT THE INSTRUMENT WAS NOT GRASPING TISSUE. THE CSR REPORTED THAT THE INSTRUMENT RELEASE TABS ARE RESPONDING. THE TSE REVIEWED LOGS AND CONFIRMED THE ISSUE WAS ON ARM1 AND THERE WERE SOME CORRESPONDING SENSOR ERRORS. CUSTOMER ENDED UP PRYING INSTRUMENT OFF STERILE ADAPTER WITH BRUTE FORCE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE CUSTOMER TO OBTAIN ADDITIONAL PATIENT/EVENT INFORMATION BUT DESPITE THE EFFORT NO PATIENT DEMOGRAPHICS AND NO ADDITIONAL EVENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2767570 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-04 N/A

    Patients

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