BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE-SITE

    MDR report key: 23206481 · Received October 2, 2025

    Report

    Report Number
    2955842-2025-40230
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Date of Event
    August 6, 2025
    Report Date
    January 12, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874113735
    PMA / PMN Number
    K130726
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE SINGLE SITE FENESTRATED BIPOLAR FORCEPS INSTRUMENT TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS INVESTIGATIONS DID NOT CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS ANALYZED AND IT WAS FOUND TO BE FULLY FUNCTIONAL. THE INSTRUMENT DID NOT HAVE ANY DAMAGED CABLES. THE INSTRUMENT HAD A BROKEN INPUT SHAFT CAUSING THE INSTRUMENT TO FAIL THE ENGAGEMENT. ADDITIONAL OBSERVATION: THE INSTRUMENT YAW INPUTS FAILED TO ENGAGE WITH THE IN-HOUSE SYSTEM'S STERILE ADAPTER DURING ALL ATTEMPTS. THE PROBABLE ROOT CAUSE OF BROKEN INPUT SHAFT IS ATTRIBUTED TO DAMAGE DURING REPROCESSING. LEFTOVER RESIDUAL CHEMICALS ON THE INPUT SHAFT CAN RESULT IN CRACKING AT HIGH TEMPERATURES OF THE AUTOCLAVE. INSUFFICIENT FLUSHING/RINSING STEPS AT THE END OF THE CLEANING PROCESS CAN ALSO RESULT IN A DAMAGED INSTRUMENT INPUT SHAFT. ONCE THE INSTRUMENT IS RECOGNIZED ON THE DA VINCI SYSTEM, ENGAGEMENT GETS CHECKED. THE ENGAGEMENT SEQUENCE RUNS FOR EACH INSTALLATION OF THE INSTRUMENT TO ENSURE PROPER MATING AND TRANSMISSION OF FORCE BETWEEN USM CARRIAGE OUTPUTS, INSTRUMENT STERILE ADAPTER, AND INSTRUMENT INPUT DISKS. SUCCESSFUL ENGAGEMENT IS DETECTED BY DRIVING THE INSTRUMENT STERILE ADAPTER THROUGH A PREDEFINED TRAJECTORY. THE PROBABLE ROOT CAUSE OF ENGAGEMENT FAILURES IS ATTRIBUTED TO AN OVER-CONSTRAINED DESIGN CONDITION BETWEEN THE MATING PARTS OF THE INSTRUMENT AND INSTRUMENT STERILE ADAPTER DISKS. CORRECTION TO SECTION D: - PRIMARY PRODUCT BATCH/LOT NUMBER WAS UPDATED TO K10250612 0051. - PRIMARY PRODUCT UDI NUMBER WAS UPDATED TO (B)(4).

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI), HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS HAD A DAMAGED WIRE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER REPORTED THAT THE FULL LOT NUMBER OF THE INSTRUMENT WAS UNKNOWN. THE CUSTOMER CLARIFIED THAT THE ISSUE WITH THE INSTRUMENT WAS THAT IT HAD A DAMAGED WIRE. THE CUSTOMER CONFIRMED THAT THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND FOUND THE WIRE DAMAGE PRIOR TO USE. THERE WAS NO PATIENT INJURY AS A RESULT OF THE INSTRUMENT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318225 SINGLE-SITE FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 478093-03 K10250612 0051 10886874113735

    Patients

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