BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 17709104 · Received September 8, 2023

    Report

    Report Number
    2955842-2023-18320
    Event Type
    Malfunction
    Date Received
    September 8, 2023
    Date of Event
    July 30, 2023
    Report Date
    August 15, 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

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE HARMONIC ACE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BLADE BROKEN. FAILURE ANALYSIS INVESTIGATIONS REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE BLADE BROKE AT ROUGHLY 0.37¿ FROM THE BASE AND THE BROKEN PIECE WAS RETURNED. REVIEW OF THE PROVIDED IMAGE WAS COMPLETED BY A REGULATORY POST MARKET SURVEILLANCE ANALYST AND THE FINDING WAS CONSISTENT WITH THE COMPLAINT OF BROKEN BLADE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON REQUESTED TO EXCHANGE THE HARMONIC ACE INSTRUMENT. THE CUSTOMER THEN FOUND THE BLADE WAS CRACKED. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF THE SAME KIND. THERE WAS NO REPORT OF FRAGMENTS FALLING INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. THE INSTRUMENT BLADE COMPLETELY BROKE OFF DURING CENTRAL PROCESSING. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ISI CLINICAL SALES REPRESENTATIVE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE, BUT UNKNOWN IF THERE WAS ANY DAMAGE. THE CUSTOMER CONFIRMED THAT THE INSTRUMENT BLADE REMAINED ATTACHED TO THE INSTRUMENT AND DID NOT FALL AT ANY POINT DURING THE PROCEDURE. THE CUSTOMER FOUND THE BLADE BECAME FRACTURED VIA ENDOSCOPY AND EXCHANGED THE INSTRUMENT. NO ADDITIONAL SURGICAL PROCEDURE OR POST-OPERATIVE TESTS WERE PERFORMED. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED, AND THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. BOTH INSTRUMENT AND CANNULA HAD NO OTHER DAMAGE AFTER THE EVENT OCCURRED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457246 NONE HARMONIC ACE NAY INTUITIVE SURGICAL, INC 480275-08 L90220404 0219 10886874112738

    Patients

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