BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19102214 · Received April 12, 2024

    Report

    Report Number
    2955842-2024-13183
    Event Type
    Malfunction
    Date Received
    April 12, 2024
    Date of Event
    March 14, 2024
    Report Date
    April 15, 2024
    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
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED ARM 1 TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM WAS INSPECTED PRIOR TO USE AND NOTHING OUT OF THE ORDINARY WAS NOTED. THE ISSUE WAS IDENTIFIED DURING PROCEDURE AFTER PORTS HAD BEEN PLACED ON THE PATIENT. THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. ARM 1 WAS ABANDONED OR DISABLED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO INJURY TO THE PATIENT. PATIENT DEMOGRAPHIC INFORMATION COULD NOT BE PROVIDED. ISI REVIEWED THE SITE¿S COMPLAINT HISTORY, WHICH REVEALED (B)(4) IS A RELATED RECORD OF (B)(4). RFE REPORT REVIEW WAS PERFORMED. PER THE REVIEW, THE FOLLOWING WAS CONFIRMED: THE MEDIASTINAL MASS RESECTION PROCEDURE TOOK PLACE ON (B)(6) 2024 VIA SYSTEM # SK1315. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY TSE. INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERROR(S): /31199/THE AC 1E DETECTED THAT THE SERVO SYNC WAS UNLOCKED. IMAGE(S) AND/OR VIDEO CLIP(S) ASSOCIATED WITH THIS REPORTED EVENT WERE NOT SUBMITTED FOR REVIEW. THE INVESTIGATION TO DETERMINE THE CAUSE OF THIS REPORTED EVENT IS CURRENTLY IN PROGRESS. AS SUCH, THE PROBABLE ROOT CAUSE CANNOT YET BE DETERMINED BASED ON THE INFORMATION PROVIDED. COMPLAINTS ARE TRACKED VIA THE QMS PROCESSES PER (B)(4) (QUALITY DATA REVIEW MEETINGS).

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL SURGICAL MANIPULATOR (USM) HAS BEEN RETURNED AND THE REPORTED FAILURE WAS CONFIRMED. SYSTEM LOGS SHOWED MULTIPLE 31199, 25730, 40084, AND 32097 ERRORS OCCURRING DURING THE TIME PERIOD POINTING TOWARDS THE PARALLELOGRAM. THE USM WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WHERE IT TRIGGERED NO ERRORS. THE USM WAS ALSO TESTED ON A PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM (PFTP) WHERE IT FAILED THE FIBER TEST ON THE PARALLELOGRAM. A GOLDEN PARALLELOGRAM FIBER WAS INSTALLED, AND THE UNIT PASSED THE FIBER TEST ON RETRY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MEDIASTINAL MASS RESECTION SURGICAL PROCEDURE, THE CUSTOMER REPORTED AN ERROR ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) 1. THE CUSTOMER STATED THAT THE ISSUE WAS ONGOING, BUT THEY DIDN'T CALL IN THE ERROR THE PREVIOUS DAY. THE CUSTOMER STATED USM1 ERRORED OUT, BUT IT DIDN'T HAVE AN INSTRUMENT INSTALLED AND WASN'T BEING USED. THE ISI TSE VIEWED SYSTEM LOGS AND SAW A 31199-ERROR POINTING TO THE USM 1 AXES CONTROLLER SPAR (ACS). LOGS FROM THE PREVIOUS DAY SHOWED ERROR 25730 FOR USM 1-ACS. THE SITE WAS COMPLETING THE PROCEDURE AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM WAS INSPECTED PRIOR TO USE AND NOTHING OUT OF THE ORDINARY WAS NOTED. THE ISSUE WAS IDENTIFIED DURING THE PROCEDURE AFTER PORTS HAD BEEN PLACED ON THE PATIENT. THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. THE USM 1 WAS ABANDONED OR DISABLED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO INJURY TO THE PATIENT.

    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
    1469408 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-39 N/A 00886874110720

    Patients

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