BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17992935 · Received October 23, 2023

    Report

    Report Number
    2955842-2023-19531
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    October 3, 2023
    Report Date
    October 3, 2023
    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
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE DISTAL SET-UP JOINT (DSUJ) WAS ANALYZED AND FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED THE CUSTOMER REPORTED COMPLAINT VISUALLY. DURING INSPECTION, FA NOTICED THAT THE PINS ON THE SETUP FRU LOWER (SFL) WERE BROKEN OFF THE PRINTED CIRCUIT ASSEMBLY (PCA) BOARD. FA INSTALLED A GOLDEN SFL TO TEST THE UNIT ON PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM (PFTP). THE DSUJ PASSED ALL TEST WITH THE GOLDEN SFL. DURING TEST, FA NOTICED THAT THE DSUJ WOULD SHIFT FROM LEFT TO RIGHT WHEN THE BRAKES WERE ENGAGED . AS A FIX, THE SFL PCA AND THE WRIST BRAKE WERE REPLACED.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED 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 ISI FSE REPLACED THE OUTER DISTAL SET UP JOINT TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE PRODUCT INVOLVED WITH THIS COMPLAINT; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. A FOLLOW-UP MDR WILL BE SUBMITTED AFTER FAILURE ANALYSIS INVESTIGATION AND IF ADDITIONAL INFORMATION IS OBTAINED. .

    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 HYSTERECTOMY WITH SACROCOLPOPEXY SURGICAL PROCEDURE, THE UNIVERSAL SURGICAL MANIPULATOR 1 (USM) WAS FOUND TO BE LOOSE, AND WIGGLED. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: USM1 WAS DISABLED DUE TO THE USM HAVING TOO MUCH LOOSE MOVEMENT. THERE WERE NO REPORTS OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1578712 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-55 N/A 00886874110720

    Patients

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