BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 18167692 · Received November 20, 2023

    Report

    Report Number
    2955842-2023-20474
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Date of Event
    September 22, 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
    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) RECEIVE THE HARMONIC ACE INSTRUMENT FOR FAILURE ANALYSIS. INSPECITON FOUND A BROKEN BLADE ROUGHLY 0.152" FROM THE BASE. 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). THE HARMONIC ACE WAS PLACED ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED RECOGNITION AND ENGAGEMENT ON MULTIPLE ATTEMPTS. THE CLAMPING ARM OPENED AND CLOSED WITH NO ISSUES. A REVIEW OF THE LOG FOUND NO ENGAGEMENT FAILURES. THE ALLEGED RECOGNITION ISSUE WAS NOT CONFIRMED FURING FAILURE ANALYSIS. A REVIEW OF THE SUBMITTED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) REGULATORY POST MARKET SURVEILLANCE (RPMS) ANALYST. THE IMAGE SHOWS A SYSTEM PROMPT INDICATING THAT THE INSTRUMENT HAS MET ITS END OF LIFE. THIS MAY HAVE BEEN THE ALLEGED SYSTEM PROMPT RELATED TO THE INSTRUMENT OBSERVED BY THE USER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT ALLEGEDLY FAILED RECOGNITION. THE USER COMPLETED THE PLANNED PROCEDURE USING A BACKUP INSTRUMENT WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER STATED THAT INSPECTION UPON REMOVAL IDENTIFIED THAT THE INSTRUMENT WAS DAMAGED. THERE WAS NO FRAGMENT THAT FELL INSIDE THE PATIENT CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523470 NONE HARMONIC ACE NAY INTUITIVE SURGICAL, INC 480275-08 0041 10886874112738

    Patients

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