BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE-SITE

    MDR report key: 17936346 · Received October 13, 2023

    Report

    Report Number
    2955842-2023-19199
    Event Type
    Malfunction
    Date Received
    October 13, 2023
    Date of Event
    January 6, 2023
    Report Date
    September 19, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874113752
    PMA / PMN Number
    K152448
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 WRISTED NEEDLE DRIVER INSTRUMENT WAS ANALYZED AND FOUND TO EXHIBIT IMPRECISE MOTION. VISUAL INSPECTION FOUND NO ISSUES AT THE DISTAL END. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT DID NOT MOVE INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE INSTRUMENT MOVEMENTS WERE IMPRECISE (NORMAL BUT NON-EXACT WITHIN JOINT LIMITS AND IN THE EXPECTED DIRECTION WITH VIBRATIONS OR SMALL-SCALE DITHERING.) THE COMPLAINT REGARDING ABNORMAL MOVEMENT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THE WRISTED NEEDLE DRIVER INSTRUMENT HAS BEEN FURTHER EVALUATED BY THE ISI FAILURE ANALYSIS ENGINEER (ADVANCED FAILURE ANALYSIS) AND THE INITIAL FAILURE ANALYSIS WAS CONFIRMED. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND CONFIRMED TO EXHIBIT UNINTUITIVE MOTION. IT WAS OBSERVED THAT WHEN ATTEMPTING TO EXECUTE THE ROLL MOTION, THE WRIST MOVED INTUITIVELY BUT IN THE OPPOSITE DIRECTION OF THE MASTER TOOL MANIPULATOR (MTM) COMMAND. WHEN MANUALLY MANIPULATING THE ROLL GEAR, THE MAIN TUBE DOES NOT FOLLOW THE MOTION. IT WAS OBSERVED THAT THE ROLL GEAR WAS BROKEN WHICH CAUSED THE MOTION FAILURES AS IT IS NO LONGER CONNECTED TO THE MAIN TUBE. AN ISI CLINICAL DEVELOPMENT ENGINEERING (CDE) REPLICATED THE CUSTOMER REPORTED ISSUE. THE WRISTED NEEDLE DRIVER INSTRUMENT WAS DRIVEN ON A SYSTEM AND RESULTED IN CONTROLLED MOTION IN AN UNEXPECTED PITCH/YAW DIRECTION. INSTRUMENTS ALSO HAD LIMITED RANGE ROTATIONAL MOTION WHEN COMMANDED BY THE USER. THERE WAS NO UNCONTROLLED MOTION OBSERVED. THE MOTION ISSUES WERE IMMEDIATELY DETECTABLE WHEN THE INSTRUMENT WAS TAKEN INTO FOLLOWING AND THE EFFECT OF THE FAILURE PREVENTED THE USER FROM BEING ABLE TO COMPLETE ANY SURGICAL TASKS. THE EVALUATION ALSO CONFIRMED THAT AT FULL INSTRUMENT INSERTION, THE ROLL OUTPUT GEAR STILL RESIDES OUTSIDE OF THE CANNULA SEAL, WHICH WOULD PREVENT FRAGMENTS FROM FALLING INSIDE THE PATIENT DURING SINGLE INCISION PROCEDURES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TIP OF THE WRISTED NEEDLE DRIVER INSTRUMENT TIP HAD NO SUFFICIENT MOVEMENT. A BACKUP INSTRUMENT OF SAME KIND WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE WRISTED NEEDLE DRIVER INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITY. THE CUSTOMER CONFIRMED THAT THE INSTRUMENT JAW MOVEMENT DID NOT MATCH THE ACTION INTENDED BY THE SURGEON PERSISTENTLY. THE ISSUE OCCURRED WHILE THE SURGEON¿S HEAD WAS INSIDE THE SURGEON CONSOLE (SC)¿S HIGH RESOLUTION STEREO VIEWER AND THE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS FROM THE SSC. THE TIMING OF INSTRUMENT MOVEMENT WAS NOT APPROPRIATE. NO SHAKINESS/ FRICTION/ EXTERNAL COLLISIONS WAS EXPERIENCED/OBSERVED. THERE WAS NO INSTRUMENT-TO-INSTRUMENT OR SYSTEM ARM-TO-ARM INTERFERENCE. THE DRAPE NUMBER WAS UNKNOWN, AND THE DRAPE WOULD NOT BE RETURNED. THERE WAS NO INJURY TO THE PATIENT AS RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585278 SINGLE-SITE WRISTED NEEDLE DRIVER NAY INTUITIVE SURGICAL, INC 478115-03 T10220920 0015 00886874113752

    Patients

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