BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 15636286 · Received October 19, 2022

    Report

    Report Number
    2955842-2022-14699
    Event Type
    Malfunction
    Date Received
    October 19, 2022
    Date of Event
    September 21, 2022
    Report Date
    September 21, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119815
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATIONS DID NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT. FA FOUND THE PRIMARY FINDING OF COULD NOT REPRODUCE - CANNOT VERIFY EXTERNAL EVENT TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT WAS FULLY FUNCTIONAL. ADDITIONAL STEPS/TEST ATTEMPTS TO FURTHER SUPPORT COULD NOT REPRODUCE (CNR) FINDINGS: VISUAL INSPECTION OF THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT FOUND NO PHYSICAL OR COSMETIC DAMAGE ON THE DISTAL END. THE HOUSING WAS REMOVED FROM THE BACK END, NO DAMAGE WAS FOUND. A NEEDLE HANDLING AND CUT TEST WERE BOTH PERFORMED WHILE THE INSTRUMENT WAS INSTALLED ON AN IN-HOUSE SYSTEM AND PASSED. THERE WAS NO PROBLEM DETECTED. NO IMAGE OR VIDEO WAS AVAILABLE FOR REVIEW. A REVIEW OF THE INSTRUMENT LOG FOR THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT (PART NUMBER 471309-15, LOT/SERIAL NUMBER (B)(4). ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THIS REVIEW OF THE LOGS, THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WAS LAST USED IN A PROCEDURE ON (B)(6) 2022 VIA SYSTEM SERIAL# (B)(4). THE ALLEGED INSTRUMENT HAD 5 USES REMAINING AFTER THIS LAST USAGE. THIS COMPLAINT IS REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WOULD NOT MOVE IN THE DESIRED DIRECTION. 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. FAILURE ANALYSIS COULD NOT CONFIRM THE UNINTUITIVE MOTION ISSUE ON THE INSTRUMENT. THE INSTRUMENT WAS FULLY FUNCTIONAL. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. IMPLANT DATE IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INITIAL REPORTER INFORMATION IS NOT AVAILABLE. IND/PREANDA PROTOCOL # AND ADVERSE EVENT TERM(S) ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WOULD NOT MOVE IN THE DESIRED WAY AND THE SURGEON COULD NOT PERFORM ACCURATE SUTURING ON THE TISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT IS DESIGNED TO GRAB AND MANIPULATE NEEDLES TO ENABLE SUTURING DURING A DA VINCI ASSISTED SURGICAL PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO ABNORMALITY WAS IDENTIFIED. THE INSTRUMENT NON INTUITIVE MOTION ISSUE WAS PERSISTENT. THE ISSUE OCCURRED WITH THE SAME INSTRUMENT ON THE SAME SYSTEM ARM. THE CUSTOMER DID NOT EXCHANGE THE DRAPE AT ANY TIME DURING PROCEDURE. THE DRAPE WOULD NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2920695 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-15 K11220418 0282 00886874119815

    Patients

    Seq Age Sex Outcome Treatment
    1 Female CONCOMITANT MEDICAL PRODUCTS: DA VINCI INSTRUMENTS AND ACCESSORIES