BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 16603673 · Received March 23, 2023

    Report

    Report Number
    2955842-2023-11500
    Event Type
    Malfunction
    Date Received
    March 23, 2023
    Date of Event
    February 14, 2023
    Report Date
    February 28, 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
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO ADD A FIELD ACTION REFERENCE IN FIELD H9.

    Additional Manufacturer Narrative · 0

    ADVANCED FAILURE ANALYSIS (FA) INVESTIGATION WAS COMPLETED AND THE FOLLOWING INFORMATION WAS OBTAINED: THIS RETURNED PRODUCT WAS TRANSFERRED TO THE ENGINEERING TEAM FOR FURTHER INVESTIGATION AND ADDITIONAL ANALYSIS WAS PERFORMED ON THE INSTRUMENT BY AN ADVANCED FAILURE ANALYSIS ENGINEER (AFAE). THE INITIAL FINDINGS WERE PARTIALLY CONFIRMED. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND INTUITIVE MOTION WAS TESTED. THE INSTRUMENT WAS TESTED WITH THE GRIPS OPEN AND WAS FOUND TO PASS INTUITIVE MOTION. THE GRIPS MOVED SMOOTHLY AND PRECISELY WITH THE MASTER TOOL MANIPULATOR (MTM) COMMAND. THE CUSTOMER REPORTED COMPLAINT WAS UNABLE TO BE REPRODUCED OR VERIFIED. THE PREVIOUSLY OBSERVED NON-INTUITIVE MOTION WAS ONLY OBSERVED WITH THE GRIPS CLOSED. HOWEVER, THE INSTRUMENT CONTAINS A FORCE AMPLIFICATION PULLEY THAT GENERATES A HIGHER GRASPING FORCE THAN OTHER INSTRUMENTS; THEREFORE, WHEN THE GRIPS ARE CLOSED, NON-INTUITIVE MOTION MAY BE OBSERVED. THIS UNEXPECTED, JERKING TYPE MOTION IS HOW THE DESIGN IS SUPPOSED TO WORK, AS THE USERS ARE NOT SUPPOSED TO BE ARTICULATING THE WRIST WITH THE GRIPS CLOSED FOR THE FORCE AMP PULLEY INSTRUMENTS. THEREFORE, THE INTUITIVE MOTION TEST SHOULD BE PERFORMED AND EVALUATED WITH THE GRIPS OPEN. IT WAS CONFIRMED THAT THE INSTRUMENT DID NOT EXHIBIT ANY VISUAL DAMAGE. THE INSTRUMENT WAS FOUND TO BE FULLY FUNCTIONAL.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE NON-INTUITIVE MOTION OF THE MLCA INSTRUMENT, 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 MLCA INSTRUMENT WAS ANALYZED AND FOUND TO HAVE NON-INTUITIVELY MOTION. A VISUAL INSPECTION FOUND NO SIGNS OF PHYSICAL DAMAGE. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT EXHIBITED IMPRECISE MOTION WHEN THE MASTER TOOL MANIPULATORS (MTMS) WERE MANIPULATED. THE INSTRUMENT WOULD MOVE PARTIALLY IN THE INTENDED DIRECTION BUT WOULD JERK IN ANOTHER DIRECTION WITHOUT BEING DIRECTED. THE INSTRUMENT PASSED THE CLIP TEST ON TWO OUT OF TWO ATTEMPTS. THE COMPLAINT REGARDING THE NON-INTUITIVE MOTION OF THE MLCA INSTRUMENT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER-REPORTED ISSUE. THE PROBABLE ROOT CAUSE OF THE UNEXPECTED MOTION IS ATTRIBUTED TO A PARTIALLY SEATED INSTRUMENT AND SUBSEQUENT DISENGAGEMENT. UNEXPECTED MOTION IS A RESULT OF THE STERILE ADAPTER DISK PEGS ONLY BEING PARTIALLY SEATED DURING THE INSTRUMENT ENGAGEMENT ROUTINE ON THE INSTRUMENT ARM. DUE TO THIS PARTIAL ENGAGEMENT, THE INPUT DISK CONTROLLING THE INSTRUMENT GRIP COULD DISENGAGE SOMETIME AFTER THE ENGAGEMENT ROUTINE HAS REGISTERED A SUCCESSFUL GRIP ENGAGEMENT AND BEFORE THE INSTRUMENT IS INSERTED THROUGH THE CANNULA. THIS COMPLAINT IS CONSIDERED AS A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE 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

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RETROPERITONEAL NEPHRECTOMY SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER (MLCA) MOVED NON-INTUITIVELY. THE CUSTOMER USED A BACKUP MLCA INSTRUMENT TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, THE CUSTOMER COULD NOT PROVIDE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836682 ENDOWRIST MEDIUM-LARGE CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470327-12 K10220718 0133 00886874112465

    Patients

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