BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 16862504 · Received May 3, 2023

    Report

    Report Number
    2955842-2023-12351
    Event Type
    Malfunction
    Date Received
    May 3, 2023
    Date of Event
    January 16, 2023
    Report Date
    April 6, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112465
    PMA / PMN Number
    K131861
    Removal / Correction Number
    ISIFA2022-05-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER INSTRUMENT NON-INTUITIVE MOVEMENT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WAS ANALYZED, AND FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF FAILED ENGAGEMENT TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT FAILED MECHANICAL ENGAGEMENT WHEN PLACED IN THE SYSTEM. INSTRUMENT INPUTS FAILED TO ENGAGE WITH THE STERILE ADAPTER IN MULTIPLE ATTEMPTS AND THE INSTRUMENT. A REVIEW OF THE LOGS SHOWED AN ERROR CODE 22020 CONFIRMING THE ENGAGEMENT FAILURE. ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS THAT THE INSTRUMENT WAS FOUND TO HAVE AN INPUT DISK BROKEN. INPUT DISK 6 WAS NOT COMPLETELY DETACHED FROM THE BASE OF THE HOUSING. THE COMPLAINT REGARDING NON-INTUITIVE MOTION WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. ONCE THE INSTRUMENT IS RECOGNIZED ON THE DA VINCI SYSTEM, ENGAGEMENT GETS CHECKED. THE ENGAGEMENT SEQUENCE RUNS FOR EACH INSTALLATION OF THE INSTRUMENT TO ENSURE PROPER MATING AND TRANSMISSION OF FORCE BETWEEN USM CARRIAGE OUTPUTS, INSTRUMENT STERILE ADAPTER, AND INSTRUMENT INPUT DISKS. SUCCESSFUL ENGAGEMENT IS DETECTED BY DRIVING THE INSTRUMENT STERILE ADAPTER THROUGH A PREDEFINED TRAJECTORY. THE PROBABLE ROOT CAUSE OF ENGAGEMENT FAILURES IS ATTRIBUTED TO AN OVER-CONSTRAINED DESIGN CONDITION BETWEEN THE MATING PARTS OF THE INSTRUMENT AND INSTRUMENT STERILE ADAPTER DISKS. THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT UNDERWENT ENGAGEMENT IMPROVEMENTS THROUGH A SOFTWARE UPDATE. THE INSTRUMENT STERILE ADAPTER ON THE ARM DRAPE ALSO UNDERWENT A DESIGN CHANGE THAT ADDED A TILTING FEATURE TO IMPROVE ENGAGEMENT BETWEEN THE USM, DRAPE, AND INSTRUMENT. NO ADDITIONAL ACTIONS ARE REQUIRED GIVEN THAT THE SOFTWARE AND DESIGN UPDATES HELPED TO MITIGATE ENGAGEMENT FAILURES. THE PROBABLE ROOT CAUSE OF BROKEN INPUT DISKS IS ATTRIBUTED TO USE AND REPROCESSING CONDITIONS. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT MOVED WITH UNINTUITIVE MOTION (E.G. THE INSTRUMENT UNEXPECTEDLY JERKED/JUMPED/SWUNG/BOWED, MOVED IN AN UNEXPECTED/UNINTENDED/UNKNOWN WAY). UNINTUITIVE MOTION COULD LEAD TO SUBSEQUENT TISSUE DAMAGE. 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 A DA VINCI-ASSISTED BILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT HAD NON-INTUITIVE MOTION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) HAS MADE FOLLOW-UP ATTEMPT TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533036 ENDOWRIST MEDIUM-LARGE CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470327-12 K10220801 0090 00886874112465

    Patients

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