BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 18187612 · Received November 21, 2023

    Report

    Report Number
    2955842-2023-20462
    Event Type
    Injury
    Date Received
    November 21, 2023
    Date of Event
    October 18, 2023
    Report Date
    October 24, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874112738
    PMA / PMN Number
    K143132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE FOR ADDITIONAL INFORMATION, AND THE FOLLOWING DETAILS WERE PROVIDED: THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NOTHING OUT OF THE ORDINARY WAS FOUND. SHORTLY AFTER THE OPERATION BEGAN, THE SYSTEM SHOWED A "REDUCE THE PRESSURE OF THE CUTTER HEAD" MESSAGE, BUT AFTER RE-INSTALLATION, THE INSTRUMENT STILL COULD NOT BE USED. AFTER PULLING OUT THE INSTRUMENT AGAIN, IT WAS FOUND THAT THE CUTTER HEAD WAS CRACKED AND BROKEN. IT WAS CONFIRMED THAT THE SYSTEM PROMPTED THE USER TO REDUCE THE TOOL HEAD PRESSURE; WHEN THE INSTRUMENT WAS REINSTALLED, THE ERROR MESSAGE APPEARED AGAIN. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. IT WAS UNKNOWN FROM WHICH VESSEL AND/OR TISSUE THE BLEEDING WAS OBSERVED. THE CAUSE OF THE UNEXPECTED BLEEDING WAS NORMAL INTRAOPERATIVE BLEEDING, AS THE INSTRUMENTS COULD NOT STIMULATE HEMOSTASIS. THE AMOUNT OF BLOOD LOSS WAS UNKNOWN. THE BLEEDING WAS RESOLVED VIA THE USE OF GAUZE AND CAUTERY. IT WAS UNKNOWN IF ANY BLOOD TRANSFUSIONS WERE REQUIRED. IT WAS UNKNOWN IF THERE WAS ANY SERIOUS DETERIORATION OR CLINICAL INSTABILITY DURING THE TIME IT TOOK TO GET AND INSTALL A BACKUP INSTRUMENT. THE PROCEDURE WAS PERFORMED IN RESPONSE TO A DIAGNOSIS OF THYROID CANCER.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT ASSOCIATED WITH THIS COMPLAINT, AND A FAILURE ANALYSIS (FA) INVESTIGATION WAS COMPLETED. FA CONFIRMED THE CUSTOMER REPORTED COMPLAINT REGARDING A CRACKED AND BROKEN CUTTER HEAD. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN BLADE AS THE PRIMARY FAILURE. THE BLADE BROKE AT ROUGHLY .195¿ FROM THE BASE, AND THE BROKEN PIECE WAS NOT RETURNED. 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 CEASE TO WORK ACCORDINGLY ONCE IT DETECTS ANY BLADE DAMAGE. AN IMAGE ASSOCIATED WITH THIS EVENT WAS SUBMITTED BY THE SITE FOR EVALUATION, AND A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED BY AN ISI CLINICAL DEVELOPMENT ENGINEER (CDE). PER THE CDE, IF THE TRANSLATION IN THE REPORTED COMPLAINT IS ACCURATE, THE ERROR MESSAGE SEEN IN THE IMAGE IS CONSISTENT WITH A DAMAGED BLADE. WITHOUT THE AVAILABILITY OF A PROCEDURE VIDEO, A ROOT CAUSE CANNOT BE CONFIRMED, BUT THIS IS OFTEN ATTRIBUTED TO INTRA-OPERATIVE COLLISIONS, USING OTHER INSTRUMENTS TO CLEAN THE BLADE OF THE HARMONIC ACE INTRA-OPERATIVELY, OR ATTEMPTING TO GRASP AND FIRE ON HARD OBJECTS LIKE CLIPS OR STAPLES. REPLACING THE DAMAGED INSTRUMENT WITH A BACK-UP INSTRUMENT IS THE RECOMMENDED COURSE OF ACTION IN THIS CASE. PER A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE, NO RELATED SYSTEM ERRORS OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT.

    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 THYROIDECTOMY PROCEDURE, THE HARMONIC ACE INSTRUMENT BROKE, RESULTING IN INCREASED BLOOD LOSS SHORTLY AFTER THE OPERATION BEGAN. A MESSAGE APPEARED ON THE ETHICON GENERATOR STATING, "REDUCE THE PRESSURE OF THE CUTTER HEAD; RESTART THE INSTRUMENT TO CONTINUE." THE INSTRUMENT WAS RE-INSTALLED, BUT IT WAS STILL NOT WORKING PROPERLY. THE CUSTOMER REMOVED THE INSTRUMENT FROM THE PATIENT AGAIN, AND THEY FOUND THAT THE CUTTER HEAD HAD CRACKED AND BROKEN. THE PROCEDURE WAS COMPLETED WITH A NEW HARMONIC ACE INSTRUMENT, WITH A DELAY OF 15 MINUTES. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE FOR ADDITIONAL INFORMATION; HOWEVER, AT THE TIME OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673902 NONE HARMONIC ACE NAY INTUITIVE SURGICAL, INC 480275-08 L10221127 10886874112738

    Patients

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