BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 21792755 · Received April 7, 2025

    Report

    Report Number
    2955842-2025-13672
    Event Type
    Malfunction
    Date Received
    April 7, 2025
    Date of Event
    January 31, 2025
    Report Date
    March 18, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE THE PIVOTING CLAMP DISLODGED FROM THE SECTOR GEAR. AS A RESULT, THE INSTRUMENT GRIPS DO NOT OPEN OR CLOSE WHEN TURNING THE GRIP KNOB. THE INSTRUMENT WAS FOUND TO HAVE IMPRECISE MOTION. THE INSTRUMENT GRIPS DID NOT OPEN OR CLOSE WHEN TURNING THE INSTRUMENTS GRIP KNOB IN EITHER DIRECTION. THIS WAS A RESULT OF THE PIVOT CLAMP BEING DISLODGED FROM THE SECTOR GEAR INSIDE OF THE HOUSING. THE INSTRUMENT WAS FOUND TO HAVE A BENT PROXIMAL DRIVE ROD WHICH IS CLAMPED BY THE PIVOTING CLAMP. THE INSTRUMENT WAS FOUND TO HAVE A DAMAGED SECTOR GEAR. THE GRIP SECTOR GEAR WAS FOUND TO HAVE SCRATCHES OR ABRASIONS WHICH COULD HAVE BEEN CAUSED WHEN THE PIVOTING CLAMP BECAME DISLODGED. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO DAMAGE DURING USE, WHICH MAY RESULT FROM AN ACCIDENTAL DROP OF THE INSTRUMENT OR INADVERTENT COLLISIONS WITH OTHER INSTRUMENTS OR HARD SURFACES.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS CONFIRMED INITIAL FINDINGS. THE INSTRUMENT WAS FOUND TO HAVE A DISLODGED PIVOT CLAMP FROM THE ROLL SECTOR GEAR. THE DISLODGED CLAMP CAN RESULT IN THE IMPRECISE MOTION OBSERVED, SPECIFICALLY THE GRIPS NOT OPENING AND CLOSING, AS THE PIVOT CLAMP COUPLES THE DRIVE ROD TO THE ROLL SECTOR'S UP AND DOWN MOTION WHICH CONTROLS THE INSTRUMENT'S GRIPS. THE INSTRUMENT WAS TRANSFERRED TO DESIGN ENGINEERING FOR FURTHER ANALYSIS, BUT NO ADDITIONAL FINDINGS WERE FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MEDIASTINAL MASS RESECTION SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WOULD NOT CLOSE. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785758 ENDOWRIST SP MEDIUM-LARGE CLIP APPLIER NAY INTUITIVE SURGICAL, INC 430005-52 S10190319 0003

    Patients

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