BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21306088 · Received February 4, 2025

    Report

    Report Number
    2955842-2025-01171
    Event Type
    Malfunction
    Date Received
    February 4, 2025
    Date of Event
    December 24, 2024
    Report Date
    January 6, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112670
    PMA / PMN Number
    K150837
    Removal / Correction Number
    ISIFA2024-09-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS WAS PERFORMED. THE HORIZON SMALL CLIP APPLIER INSTRUMENT WAS FOUND TO HAVE A FRAYED GRIP CABLE AT THE IDLER PULLEYS. SOME WIRES WERE BROKEN, BUT THE CABLE ITSELF WAS NOT FULLY BROKEN. THERE WAS NO CORROSION OR CONTAMINATION OBSERVED ON THE CABLE THAT WOULD OCCUR FROM IMPROPER FLUSHING OR RINSING DURING REPROCESSING. FURTHER INSPECTION FOUND NO ABNORMALLY SHARP OR DAMAGED COMPONENTS THAT COULD HAVE CONTRIBUTED TO THE CABLE BREAKING. THE PROBABLE ROOT CAUSE OF CABLE BREAKAGE/FRAYED, WHETHER PARTIAL OR FULL, IS ATTRIBUTED TO DAMAGE TO THE CABLE THROUGH EXTERNAL COLLISIONS, DURING USE, OR DURING REPROCESSING.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE HORIZON SMALL CLIP APPLIER INSTRUMENT FOR EVALUATION, BUT EVALUATION HAS NOT BEEN COMPLETED AS OF THE DATE OF THIS REPORT. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. THE ISI FAILURE ANALYSIS ENGINEER (FAE) CONFIRMS THAT THE INSTRUMENT HAS THE GRIP PIN AND CLEVIS PIN.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE HORIZON SMALL CLIP APPLIER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE GRIP INPUT DISK SEVEN BROKEN INSIDE THE HOUSING. FOR CLARIFICATION, THE BROKEN INPUT DISK IS ROOT CAUSE OF LOSS OF ARTICULATION AT THE DISTAL END. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO USE AND REPROCESSING CONDITIONS. THE INPUT DISK COMPONENT CONSISTS OF ULTEM OR PEEK MATERIAL INSERT MOLDED OVER A STEEL PIN. THE INSERT MOLDING PROCESS RESULTS IN RESIDUAL STRESS IN THE PLASTIC PORTION OF THE INPUT DISK. THESE RESIDUAL STRESSES CAN BE SUSCEPTIBLE TO CHEMICAL OR THERMAL STRESSES, WHICH CAN RESULT IN THE APPEARANCE OF CRACKS IN THE ULTEM OR PEEK MATERIAL. UNDER REPEATED OR PROLONGED CHEMICAL OR THERMAL EXPOSURE CYCLES, THESE CRACKS CAN PROPAGATE INTO LARGER CRACKS AND MAY CAUSE THE INPUT DISK TO BREAK AND SEPARATE FROM THE INSTRUMENT.

    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 RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE SCREW ON THE JAW OF THE SMALL CLIP APPLIER INSTRUMENT WAS LOOSE. THE CLIP COULD NOT INSTALL WELL. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64206 ENDOWRIST CLIP APPLIER, SMALL, HORIZON NAY INTUITIVE SURGICAL, INC 470401-07 K10220912 0106 00886874112670

    Patients

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