BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22014760 · Received May 13, 2025

    Report

    Report Number
    2955842-2025-20288
    Event Type
    Malfunction
    Date Received
    May 13, 2025
    Date of Event
    April 10, 2025
    Report Date
    April 15, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874121504
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT, HOWEVER, INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT FOR EVALUATION. REVIEW OF THE PROVIDED IMAGE (SEE ATTACHMENT - DUPLICATE RECORD) SHOWS A BROKEN INSTRUMENT MAIN TUBE CAUSING THE STUCK IN CANNULA ISSUE. ROOT CAUSE OF THE FAILURE MODE CANNOT BE CONFIRMED WITHOUT THE RETURNED DEVICE. NO FURTHER ESCALATIONS REQUIRED FOR THE IMAGE REVIEW.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE LARGE SUTURECUT NEEDLE DRIVER INSTRUMENT TO PERFORM FAILURE ANALYSIS (FA). FA WAS ABLE TO CONFIRM/REPRODUCE THE REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN MAIN TUBE AT THE DISTAL TIP. ONE PIECE MEASURING PROXIMATELY 15MM X 4MM WAS NOT RETURNED WITH THE INSTRUMENT. COMPONENTS ADJACENT TO THIS BROKEN MAIN TUBE DO NOT SHOW DAMAGE. ADDITIONAL RELATED OBSERVATION: THE INSTRUMENT WAS FOUND TO HAVE THE PROXIMAL CLEVIS DISLODGED. THE BROKEN MAIN TUBE CAUSED THE PROXIMAL CLEVIS TO BECOME DISLODGED. THE INSTRUMENT CAME BACK ATTACHED WITH THE FOLLOWING ACCESSORIES. DUE TO THE DISLODGED PROXIMAL CLEVIS, IT WAS NOT POSSIBLE TO REMOVE THE SEAL PORT AND CANNULA. THE PROBABLE ROOT CAUSE OF THE BROKEN MAIN TUBE IS ATTRIBUTED TO DAMAGE DURING USE, WHICH MAY RESULT FROM AN ACCIDENTAL DROP OF THE INSTRUMENT OR INADVERTENT COLLISIONS WITH OTHER INSTRUMENTS. EXCESSIVE SIDE LOADING ON THE INSTRUMENT CAN ALSO CAUSE THE MAIN TUBE WALL TO COLLAPSE INWARDS LEADING TO CRACKING AND SUBSEQUENT BREAKAGE. FURTHERMORE, THE DISLODGED PROXIMAL CLEVIS RESULTED FROM THE BROKEN MAIN TUBE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE LARGE SUTURECUT NEEDLE DRIVER INSTRUMENT ROTATION SHAFT WAS STUCK AND COULD NOT BE PUT BACK INTO PLACE. THE CLAMP COULD NOT BE UNSTUCK WITH THE SAFETY KEY. THE INSTRUMENT WAS REMOVED WITH THE CANNULA. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE OCCURRED ON APRIL 10, 2025, DURING AN ANTERIOR PELVECTOMY; NO FRAGMENTS WERE MISSING OR LEFT IN THE PATIENT, NO PORT ENLARGEMENT WAS NEEDED, THE ISSUE WAS RESOLVED BY REPLACING THE INSTRUMENT, AND THE PATIENT SUSTAINED NO INJURY. PATIENT DEMOGRAPHICS AND MEDICAL DETAILS WERE NOT AVAILABLE, AND THE INSTRUMENT WAS ALREADY RETURNED TO ISI.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880085 ENDOWRIST LARGE SUTURE CUT NEEDLE DRIVER NAY INTUITIVE SURGICAL, INC 471296-10 K10241107 0405 00886874121504

    Patients

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