BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FEEDBACK

    MDR report key: 24866492 · Received April 13, 2026

    Report

    Report Number
    2955842-2026-21108
    Event Type
    Malfunction
    Date Received
    April 13, 2026
    Date of Event
    March 5, 2026
    Report Date
    April 22, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874125588
    PMA / PMN Number
    K243641
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FORCE FEEDBACK FENESTRATED BIPOLAR FORCEPS WAS ANALYZED AND FOUND TO HAVE THERMAL DAMAGE TO THE YAW PULLEY. THE YAW PULLEY WAS FOUND TO HAVE CHARRING AND LOCALIZED MELTING OF BOTH BIPOLAR YAW PULLEYS, IN THE SPACE BETWEEN THE GRIPS CAUSE A STRAND OF FIBER TO STICKER GIVING THE SPLINTER LIKE ILLUSION. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. COMMON CAUSES OF THE FAILURE MODE THERMAL DAMAGE BETWEEN GRIPS INSTRUMENT BIPOLAR YAW PULLEY ARE ATTRIBUTED TO INSULATION DEGRADATION AND CARBONIZED TISSUE CREATING A CONDUCTIVE PATH. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WAS A SPLINTER ON THE RESIN TIP OF THE FORCE FEEDBACK FENESTRATED BIPOLAR FORCEPS. THE PROCEDURE WAS CONTINUED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH A NURSE FROM THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE NURSE WAS NOT PRESENT FOR THE PROCEDURE. THE DAMAGE WAS DISCOVERED DURING PRE-OPERATIVE PREPARATIONS, BUT THE TIMING OF THE DAMAGE IS UNKNOWN. THERE WAS NO REPORT OF FRAGMENTS FALLING FROM THE DEVICE WHILE USED WITHIN A PATIENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557506 FORCE FEEDBACK FORCE FEEDBACK FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 476205-17 U10250821 00886874125588

    Patients

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