BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17269836 · Received July 6, 2023

    Report

    Report Number
    2955842-2023-16839
    Event Type
    Malfunction
    Date Received
    July 6, 2023
    Date of Event
    June 6, 2023
    Report Date
    June 6, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE GRASPING FORCE OF THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT WAS WEAK. THERE WAS NO NON-INTUITIVE MOTION ISSUE. THERE WAS NO SHAKINESS OR FRICTION. THERE WAS NO PATIENT INJURY. THE ISSUE WAS RESOLVED BY RESEATING THE STERILE ADAPTER (SA). THE INSTRUMENT WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A POSSIBLE NON-INTUITIVE MOVEMENT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED FOR TROUBLESHOOTING ASSISTANCE. THE ISSUE WAS RESOLVED BEFORE THE PHONE CALL WITH THE TSE. THE TSE COULD NOT FIND ANY RELATED ERRORS IN THE LOGS UPON REVIEW. THE TSE ADVISED THE CUSTOMER TO RESEAT THE STERILE ADAPTER (SA) AND EXPLAINED THE FUNCTION OF THE FINGER CLUTCH BUTTON ON THE MTM ARMS. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED.

    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 SIGMOID COLECTOMY SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THE MOTION OF THE INSTRUMENT ON THE UNIVERSAL SIDE MANIPULATOR (USM) ARM "DID NOT LINK WELL" WHEN THE SURGEON WAS MANIPULATING THE MASTER TOOL MANIPULATORS (MTMS). THE ISSUE WAS RESOLVED BEFORE THE PHONE CALL WITH THE TSE. DURING THE CALL, TSE COULD NOT FIND ANY RELATED ERRORS IN THE LOGS UPON REVIEW. THE TSE ADVISED THE CUSTOMER TO RESEAT THE STERILE ADAPTER (SA) AND EXPLAINED THE FUNCTIONALITY OF THE FINGER CLUTCH BUTTON ON THE MTM ARMS. THE USER CONTINUED THE PROCEDURE USING ALL USM ARMS WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885378 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-33 N/A

    Patients

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