BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 15300910 · Received August 26, 2022

    Report

    Report Number
    2955842-2022-13678
    Event Type
    Malfunction
    Date Received
    August 26, 2022
    Date of Event
    June 1, 2022
    Report Date
    July 27, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112441
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SMALL GRASPING RETRACTOR INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF BROKEN PITCH CABLE. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN PITCH CABLE AT THE DISTAL END. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS MISSING FROM CLEVIS. PITCH CABLE BREAKAGE OCCURS WHEN TENSILE LOAD EXCEEDS THE ULTIMATE STRENGTH OF THE MATERIAL. THE PITCH CABLE CONSTRUCTION IS DESIGNED TO OPTIMIZE LOAD AND FATIGUE (CYCLING) CHARACTERISTICS. VARIATION IN CUSTOMER USE CONDITIONS, PROCEDURE TYPE, PATIENT ANATOMY, PRODUCT HANDLING, INSTRUMENT TIP LENGTHS, GRIP TORQUE, AND MANUFACTURING TOLERANCES ARE A FEW VARIABLES WHICH CAN INFLUENCE PITCH CABLE FAILURE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO A COMPONENT FAILURE. ADDITIONAL OBSERVATION NOT REPORTED BY SITE: THE INSTRUMENT WAS FOUND TO HAVE VARIOUS SCRATCH MARKS ON THE MAIN TUBE. THE SCRATCH MARKS WERE .120¿ - .166¿ IN LENGTH AND WERE NOT ALIGNED WITH THE TUBE AXIS. THE ROOT CAUSE OF SCRATCH MARKS /ABRASIONS INSTRUMENT MAIN TUBE IS TYPICALLY ATTRIBUTED TO MISHANDLING/MISUSE. NO IMAGES OR VIDEOS WERE SUBMITTED FOR REVIEW. A REVIEW OF THE INSTRUMENT LOG FOR PART 470318-10/ N10210705 0017 ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE SMALL GRASPING RETRACTOR WAS LAST USED ON (B)(6) 2021 ON SYSTEM (B)(4), WITH 7 LIVES REMAINING. THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING: THIS INSTRUMENT IS DESIGNED WITH TWO PITCH CABLES EACH WITH A CRIMP AT THE DISTAL END. IF A PITCH CABLE BREAKS AT THE DISTAL END, A CABLE SEGMENT AND/OR THE CRIMP COULD FALL INTO THE PATIENT. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING , THE SMALL GRASPING RETRACTOR INSTRUMENT HAD LOOSE CABLE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND THE REPORTER WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020247 ENDOWRIST SMALL GRASPING RETRACTOR NAY INTUITIVE SURGICAL, INC 470318-10 N10210705 0017 00886874112441

    Patients

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