BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 14941383 · Received July 7, 2022

    Report

    Report Number
    2955842-2022-12803
    Event Type
    Malfunction
    Date Received
    July 7, 2022
    Date of Event
    June 2, 2022
    Report Date
    June 6, 2022
    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) HAS RECEIVED THE HARMONIC ACE INSTRUMENT FOR EVALUATION, BUT THE ANALYSIS HAS NOT YET BEEN COMPLETED AS OF THE DATE OF THIS REPORT. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED FOLLOWING COMPLETION OF THE ANALYSIS AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE PROCEDURE LOG WITH THE INFORMATION PROVIDED RESULTED IN NO ADDITIONAL INFORMATION. IN ADDITION, THE INSTRUMENT BATCH SEQUENCE NUMBER WAS NOT PROVIDED, AND THE SYSTEM WAS NOT CONNECTED TO THE NETWORK TO GATHER LOGS. THEREFORE, AN INSTRUMENT LOG REVIEW OF THE PRODUCT RELATED TO THE COMPLAINT CANNOT BE PERFORMED AT THIS TIME. IMAGES OF THE HARMONIC ACE INSTRUMENT RELATED TO THIS EVENT WERE RECEIVED AND REVIEWED. THE IMAGES CONFIRMED THAT THE HARMONIC ACE INSTRUMENT BLADE WAS DETACHED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, IT WAS ALLEGED THAT THE BLADE OF THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: G3, G6, H2, AND H3 ANALYSIS INFORMATION CAN BE FOUND IN FIELDS H6 AND H10 INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF THE BROKEN BLADE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN BLADE. THE BLADE BROKE AT ROUGHLY 0.23¿ FROM THE BASE. THE BROKEN PIECE WAS NOT RETURNED WITH THE INSTRUMENT. CRACKED OR BROKEN BLADES ARE TRIGGERED BY ANY INADVERTENT CONTACT WITH STAPLES, CLIPS, OR OTHER INSTRUMENTS WHILE THE DEVICE IS ACTIVATED. IN ADDITION, SCRATCHES ON THE BLADE TIP MAY ALSO LEAD TO PREMATURE BLADE FAILURE. BLADE DAMAGE MAY BE DETECTED BY THE GENERATOR WITH A SOLID TONE OR AN ERROR. THE ROOT CAUSE OF THE ¿BROKEN INSTRUMENT BLADES¿ IS TYPICALLY ATTRIBUTED TO MISHANDLING/MISUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT BLADE BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE CUSTOMER REPLACED THE HARMONIC ACE INSTRUMENT WITH A BACK-UP INSTRUMENT OF THE SAME KIND AND COMPLETED THE PROCEDURE WITH NO REPORTED INJURY. ON 08-JUNE-2022 AND 14-JUNE-2022, INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UPS AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS NOT INSPECTED PRIOR TO USE. THE INSTRUMENT WAS IN USE FOR 20 MINUTES AND PERFORMED AS INTENDED UP UNTIL IT BROKE. THE SURGEON WAS DISSECTING TISSUE AT THE TIME OF THE EVENT. THE INSTRUMENT DID NOT MAKE CONTACT WITH ANY OTHER INSTRUMENT OR HARD MATERIAL DURING THE SURGICAL PROCEDURE. AFTER THE INSTRUMENT BLADE BROKE OFF AND FELL INSIDE THE PATIENT, THE FRAGMENT WAS VISUALLY LOCATED AND RETRIEVED DURING THE SAME PROCEDURE. AN X-RAY WAS PERFORMED, AND THE CUSTOMER CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED. THE INSTRUMENT WAS NOT REMOVED PRIOR TO THE BREAKAGE. THERE WAS NO RESISTANCE UPON FINAL REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THE SURGICAL STAFF DID NOT NOTICE ANY OTHER DAMAGE TO THE INSTRUMENT OR CANNULA AFTER THE EVENT OCCURRED. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. IT WAS CONFIRMED THERE WAS NO PATIENT HARM, INJURY OR ADVERSE OUTCOME. THE INSTRUMENT IS AVAILABLE FOR RETURN TO ISI FOR EVALUATION. A VIDEO RECORDING OF THE PROCEDURE IS NOT AVAILABLE, BUT IMAGES OF THE INSTRUMENT DAMAGE WERE PROVIDED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2722773 NONE HARMONIC ACE NAY INTUITIVE SURGICAL, INC 480275-08 L90210411 10886874112738

    Patients

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