BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 24142024 · Received January 22, 2026

    Report

    Report Number
    2955842-2026-01855
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    January 6, 2026
    Report Date
    February 25, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112328
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT: "SMALL YELLOW PLASTIC GUARD BROKE OFF THE SIDE OF THE INSTRUMENT AND WAS FOUND IN THE POCKET OF THE ENDOSCOPY DRAPE. A NEW SPATULA WAS RETRIEVED AND CASE CONTINUED." THE INSTRUMENT WAS FOUND HAVE A BROKEN DISTAL CLEVIS AT THE BASE OF THE CLEVIS. THE BROKEN PIECE WAS NOT RETURNED, MEASURING ROUGHLY 0.2115¿ X 0.2540¿ IN SIZE. CLEVIS DOES NOT SHOW ABRASIONS OR SCRATCHES ON THE OUTER SURFACE. COMPONENTS ADJACENT TO THE BROKEN CLEVIS DO NOT SHOW DAMAGE. PROBABLE ROOT CAUSE IS ATTRIBUTED TO ATTRIBUTED TO DAMAGE DURING USE, WHICH MAY RESULT FROM APPLYING EXCESS FORCE ON THE INSTRUMENT TIP DURING HANDLING, INSERTION, USAGE (OVERLOADING), OR REMOVAL. INSTRUMENT COLLISIONS WITH OTHER HAND-HELD INSTRUMENTATION OR INSTRUMENT DRIVEN OUTSIDE THE FIELD OF VIEW CAN ALSO CAUSE DAMAGE TO THE INSTRUMENT DISTAL CLEVIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE 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 PROCEDURE THE SMALL YELLOW PLASTIC GUARD BROKE OFF THE SIDE OF THE INSTRUMENT AND WAS FOUND IN THE POCKET OF THE ENDOSCOPY DRAPE. A NEW SPATULA WAS RETRIEVED AND CASE CONTINUED. PROCEDURE WAS COMPLETED WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203658 ENDOWRIST PERMANENT CAUTERY SPATULA NAY INTUITIVE SURGICAL, INC 470184-16 K10250501 0069 00886874112328

    Patients

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