BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20381503 · Received October 7, 2024

    Report

    Report Number
    2955842-2024-20305
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    August 26, 2024
    Report Date
    September 10, 2024
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PERMANENT CAUTERY SPATULA INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP CABLE AT THE YAW PULLEY. THE CABLE WAS FULLY BROKEN. THERE WAS NO DISCOLORATION, CORROSION, OR CONTAMINATION 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 INSTRUMENT WAS FOUND TO HAVE A LOOSE PITCH CABLE AT THE PROXIMAL CLEVIS. A VISUAL INSPECTION OF THE BACKEND FOUND NO EVIDENCE OF A CRACKED CLAMPING PULLEY, INPUT DISK, OR INPUT SHAFT THAT WOULD HAVE CAUSED THE LOOSE CABLE. THE INSTRUMENT WAS FOUND TO HAVE MULTIPLE INDENTATIONS/BURRS ON THE EDGE OF THE DISTAL IDLER PULLEYS. THERE WERE NO PIECES MISSING. GRIP CABLES/OTHER COMPONENTS ADJACENT TO THIS INDENTED PULLEY SHOW DAMAGE WHICH MAY INDICATE POTENTIAL MISHANDLING/MISUSE. THE INSTRUMENT GRIP CABLE WAS BROKEN. THE INSTRUMENT WAS FOUND TO HAVE A MECHANICAL INDENTATION ON MONOPOLAR YAW PULLEY. THE INSTRUMENT EXHIBITED WEAR ON THE EDGE OF THE YAW PULLEY. THE INSTRUMENT WAS FOUND TO HAVE SCRATCH MARKS/ABRASIONS ON THE EDGE AND FACE OF THE MONOPOLAR YAW PULLEY. THE SCRATCH MARKS/ABRASIONS WERE FOUND ON BOTH SIDE OF THE DISTAL CLEVIS. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN CERAMIC SLEEVE. BROKEN PIECES ARE MISSING AS A RESULT OF BREAKAGE. SIZE OF MISSING PIECE IS APPROXIMATELY 0.028# X 0.071". THE SECOND BROKEN PIECE MISSING PIECE IS APPROXIMATELY 0.101" X 0.121" IN SIZE. CERAMIC SLEEVE DOES EXHIBIT SCRATCH MARKS. THE INSTRUMENT WAS FOUND TO HAVE AN EXCESSIVE AMOUNT OF DRIED, WHITE RESIDUE ON THE CLAMPING PULLEYS FOR INPUT(S) #5 (PITCH) AND #6 (GRIP), LOCATED INSIDE THE BACKEND OF THE INSTRUMENT. THE INSTRUMENT WAS FOUND TO HAVE HAIRLINE CRACKS ON INPUT AXIS #6 (GRIP). THE UNIT PASSED ELECTRICAL CONTINUITY TEST. NO SIGN OF DAMAGE ON THE CONDUCTOR WIRE. THE COMPLAINT REGARDING A LOOSE WIRE WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CARDIAC SURGICAL PROCEDURE, THE PERMANENT CAUTERY SPATULA INSTRUMENT HAD A LOOSE CABLE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. NO FRAGMENT FELL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213333 ENDOWRIST PERMANENT CAUTERY SPATULA NAY INTUITIVE SURGICAL, INC 470184-14 K10221009 0085 00886874112328

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES.