BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 18287581 · Received December 7, 2023

    Report

    Report Number
    2955842-2023-20891
    Event Type
    Injury
    Date Received
    December 7, 2023
    Date of Event
    November 7, 2023
    Report Date
    November 9, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K143132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE REPORTED EVENT WAS CONFIRMED THROUGH FAILURE ANALYSIS INVESTIGATION. INSPECTION FOUND DAMAGE ON THE BLADE ¿ THE BROKEN PIECE WAS RETURNED FOR EVALUATION. IT IS KNOWN THAT INADVERTENT CONTACT WITH STAPLES, CLIPS, OR OTHER INSTRUMENTS WHILE THE INSTRUMENT IS ACTIVATED MAY RESULT IN A CRACKED OR BROKEN BLADE. SCRATCHES ON THE BLADE MAY LEAD TO PREMATURE BLADE FAILURE. THE SYSTEM WILL DISPLAY AN ERROR MESSAGE AND WILL SEIZE TO WORK ACCORDINGLY ONCE IT DETECTS ANY BLADE DAMAGE. A REVIEW OF THE SUBMITTED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) REGULATORY POST MARKET SURVEILLANCE (RPMS) ANALYST. THE IMAGE SHOWS THE INSTRUMENT TIP WITH OBVIOUS DETACHMENT TO THE INSTRUMENT BLADE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED OOPHORECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS NOTICED TO HAVE THE CUTTER HEAD FRACTURED. THE CUSTOMER USED A SPARE INSTRUMENT TO PROCEED WITH THE PROCEDURE. NO FRAGMENT FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS INSPECTED BEFORE USE WITH NOTHING FOUND OUT OF THE ORDINARY. THE PROCEDURE WAS NOT CONFIRMED. THE SURGICAL TASK BEING PERFORMED AS THE ISSUE OCCURRED WAS DISSECTING. THE SURGEON THINKS WHAT CAUSED THE FRAGMENT FALLING WAS AN ISSUE WITH THE QUALITY. THE INSTRUMENT WAS IN USE 30 MINUTES PRIOR TO THE ISSUE OCCURRING. THE SURGEON DID NOT NOTICE ANY FUNCTIONALITY ISSUES WITH THE INSTRUMENT DURING THE PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH OTHER INSTRUMENTS OR HARD MATERIALS. THE WRIST WAS STRAIGHTENED BEFORE REMOVAL OF THE INSTRUMENT AND NO RESISTANCE WAS NOTICED. NO DAMAGE TO THE CANNULA WAS FOUND. NO OTHER DAMAGE WAS NOTED TO THE INSTRUMENT. ALL THE FRAGMENTS WERE RETRIEVED WITH THE ENDOSCOPE. NO ADDITIONAL PROCEDURES WERE REQUIRED TO REMOVE THE FRAGMENTS. IT WAS CONFIRMED THAT ALL THE FRAGMENTS WERE RETRIEVED. NO TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259250 NONE HARMONIC ACE NAY INTUITIVE SURGICAL, INC 480275-08 L80230115 0210

    Patients

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