BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 17149090 · Received June 17, 2023

    Report

    Report Number
    2955842-2023-16418
    Event Type
    Malfunction
    Date Received
    June 17, 2023
    Date of Event
    February 7, 2023
    Report Date
    May 18, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874112738
    PMA / PMN Number
    K143132
    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 A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE HARMONIC ACE INSTRUMENT WAS ANALYZED AND DRIVEN ON AN IN-HOUSE SYSTEM. IT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. FAILURE ANALYSIS COULD NOT VERIFY THE EXTERNAL EVENT. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE BLADE OPENED AND CLOSED PROPERLY. THE INSTRUMENT WAS CONNECTED TO AN IN-HOUSE ENERGY GENERATOR. A TORQUE WRENCH WAS USED TO TIGHTEN THE ASSEMBLY UNTIL IT WAS AS TIGHT AS IT COULD BE (CLICKING SOUNDS). THE INSTRUMENT PASSED THE ENERGY RECOGNITION TEST ON 2 OUT OF 2 ATTEMPTS. NO ERRORS WERE OBSERVED. THE INSTRUMENT WAS FULLY FUNCTIONAL. THERE WAS NO PROBLEM DETECTED. ADDITIONAL OBSERVATION(S) FOUND A BROKEN CURVED BLADE AT THE DISTAL END. THE BLADE BROKE AT ROUGHLY 0.107¿ FROM THE BASE. THE BROKEN PIECE WAS NOT RETURNED WITH THE INSTRUMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS NOT RECOGNIZED. THE INSTRUMENT BLADE WAS FOUND TO BE BROKEN. A BACKUP INSTRUMENT OF THE 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 INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITY IDENTIFIED. THE CUSTOMER CONFIRMED THAT THE INSTRUMENT TIP WAS BROKEN OFF WHILE DISSECTING. NO FRAGMENT FELL INSIDE OF THE PATIENT. THERE WAS NO INTRAOPERATIVE COLLISION OR MISUSE INVOLVING THE INSTRUMENT OBSERVED. THE PROCEDURE WAS DELAYED FOR 5 MINUTES WITH NO INTRA OR POST OPERATIVE COMPLICATIONS. ACCORDING TO THE SURGEON, THIS EVENT DID NOT IMPACT THE PROCEDURE OR THE PATIENT¿S HEALTH. THERE WAS NO CONCERN ABOUT PROCEDURE DELAY CAUSING ANY LONG-TERM COMPLICATIONS WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013901 NONE HARMONIC ACE NAY INTUITIVE SURGICAL, INC 480275-08 L80230119 0332 10886874112738

    Patients

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