BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 16420026 · Received February 22, 2023

    Report

    Report Number
    2955842-2023-10814
    Event Type
    Malfunction
    Date Received
    February 22, 2023
    Date of Event
    March 21, 2022
    Report Date
    January 24, 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
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE HARMONIC ACE HEAD WAS BROKEN, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS CONFIRMED THE CUSTOMER COMPLAINT OF THE HARMONIC ACE HAVING A BROKEN HEAD. THE INSTRUMENT WAS FOUND WITH A BROKEN CURVED BLADE. A BROKEN PIECE APPROXIMATELY 0.6" X 0.1" WAS NOT RETURNED. BLADE DAMAGE MAY BE DETECTED BY THE GENERATOR WITH A SOLID TONE OR AN ERROR. COMMON CAUSES OF THE FAILURE MODE ARE TYPICALLY ATTRIBUTED TO THE USER. CRACKED OR BROKEN BLADES RESULT FROM BLADE SCRATCHES AND DAMAGE CAUSED BY CONTACT WITH OTHER INSTRUMENTS OR OTHER HARD/METAL OBJECTS DURING USE WHILE THE INSTRUMENT IS ACTIVATED. BLADE FRACTURES PROPAGATE FROM INITIAL CONTACT SITES DUE TO THE ULTRASONIC VIBRATION OF THE HARMONIC ACE BLADE, LEADING TO EVENTUAL/PREMATURE FAILURE. THE COMPLAINT REGARDING THAT THE HARMONIC ACE HEAD BEING BROKEN WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE OF A CRACKED/BROKEN BLADE IS ATTRIBUTED TO USE CONDITIONS. CRACKED OR BROKEN BLADES RESULT FROM BLADE SCRATCHES AND DAMAGE CAUSED BY CONTACT WITH OTHER INSTRUMENTS OR OTHER HARD/METAL OBJECTS (E.G., STAPLES, CLIPS, ETC.) DURING USE WHILE THE INSTRUMENT IS ACTIVATED. BLADE FRACTURES PROPAGATE FROM INITIAL CONTACT SITES DUE TO THE ULTRASONIC VIBRATION OF THE HARMONIC ACE BLADE, LEADING TO EVENTUAL/PREMATURE FAILURE (E.G., SCRATCHES AND DAMAGE RESULT IN CRACKS, WHICH THEN RESULT IN BROKEN BLADES). THIS ISSUE CAN BE RESOLVED BY USING AN ALTERNATE INSTRUMENT TO COMPLETE THE PROCEDURE. THIS ISSUE IS ALSO CAPTURED IN THE FMEA FOR THE HARMONIC ACE INSTRUMENT (1009388) VIA RISK ID 1093098. THIS ISSUE IS ASSOCIATED WITH AN ONGOING CORRECTIVE AND PREVENTIVE ACTION (CAPA) FOR THE HARMONIC ACE INSTRUMENT. THE PREVENTIVE ACTIONS ARE RELATED TO COMPARING THE PERFORMANCE OF ETHICON¿S UPDATED DESIGN TO ISI¿S VERSION THAT ETHICON SUPPLIES. NO ADDITIONAL ACTIONS ARE REQUIRED GIVEN THAT THIS ISSUE WILL CONTINUE TO BE TRACKED PER (B)(4) (QUALITY DATA REVIEW MEETINGS).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE HEAD WAS BROKEN. THERE WAS NO FRAGMENT THAT FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE NURSE CONFIRMED THAT THE HARMONIC ACE WASN'T BROKEN WHEN IT WAS INSTALLED TO THE ARM. THERE WAS NO REPORT OF FRAGMENT FALLING FROM THE DEVICE WHILE IT WAS WITHIN THE PATIENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174934 NONE HARMONIC ACE NAY INTUITIVE SURGICAL, INC 480275-08 L90210926 10886874112738

    Patients

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