BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI ENERGY

    MDR report key: 16796319 · Received April 24, 2023

    Report

    Report Number
    2955842-2023-12139
    Event Type
    Injury
    Date Received
    April 24, 2023
    Date of Event
    March 24, 2023
    Report Date
    March 30, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874117306
    PMA / PMN Number
    K191280
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUMENT WAS TRANSFERRED TO A FAILURE ANALYSIS ENGINEER (FAE) AND THE INITIAL FAILURE ANALYSIS FINDINGS WERE CONFIRMED. MICROSCOPIC INSPECTION OF THE PIN WHERE THE WASHER GOT DISLODGED SHOWED THAT THE PIN WAS INSUFFICIENTLY SWAGED WHICH LIKELY LED TO THE WASHER GETTING DISLODGED. FURTHER INVESTIGATION CONFIRMED ADDITIONAL OBSERVATIONS. THE "GOOD" SWAGE SIDE OF THE PIN HAD A PART OF THE PIVOT PIN BROKEN, EVEN THOUGH THE WASHER WAS STILL INTACT. THIS SEEMS UNLIKELY TO LEAD TO THE WASHER GETTING DISLODGED IN THE CURRENT CONDITION BUT IF THE SWAGED PIN IS BROKEN IN MORE AREAS, IT CAN POTENTIALLY LEAD TO THE WASHER GETTING DISLODGED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE SYNCHROSEAL INSTRUMENT TO PERFORM FAILURE ANALYSIS (FA) INVESTIGATION. FA WAS ABLE TO CONFIRM AND REPRODUCE THE CUSTOMER-REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A DISLODGED WASHER AT THE DISTAL END. THE DISLODGED WASHER WAS RETURNED WITH THE INSTRUMENT. THERE WERE NO MISSING CERAMIC DOTS. A REVIEW OF THE LOGS SHOWED NO ERRORS. THIS FAILURE TYPE IS TYPICALLY ATTRIBUTED TO USE CONDITIONS.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT A FRAGMENT FELL FROM THE SYNCHROSEAL INSTRUMENT INTO THE PATIENT, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST-FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THE INVESTIGATION TO DETERMINE THE CAUSE OF THIS REPORTED EVENT IS CURRENTLY IN PROGRESS. AS SUCH, THE PROBABLE ROOT CAUSE CANNOT YET BE DETERMINED BASED ON THE INFORMATION PROVIDED. THIS IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED PARAESOPHAGEAL HIATAL HERNIA SURGICAL PROCEDURE, A FRAGMENT FROM A SYNCHROSEAL INSTRUMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED IN THE SAME PROCEDURE.

    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 PARAESOPHAGEAL HIATAL HERNIA SURGICAL PROCEDURE, A FRAGMENT FELL FROM THE SYNCHROSEAL INSTRUMENT INTO THE PATIENT. DURING INTRAOPERATIVE USE, THE STAFF CLEANED THE INSTRUMENT AND PUT IT BACK INTO THE HOSPITAL. A WASHER/JOINT TIP FELL OUT INTO THE PATIENT IMMEDIATELY AFTER CLEANING THE INSTRUMENT. THEY RETRIEVED THE FRAGMENT FROM THE PATIENT WITH A LAPAROSCOPIC INSTRUMENT. THERE WERE NO DIAGNOSTIC TESTS DONE. THE PROCEDURE WAS COMPLETED. ON (B)(6) 2023, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED FROM THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR): PRIOR TO USE, THE INSTRUMENT WAS VISUALLY INSPECTED WITH NOTHING OUT OF THE ORDINARY NOTED. ALL FRAGMENTS WERE RETRIEVED, CONFIRMED BY VISUAL INSPECTION. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS REMOVED DURING THE PROCEDURE PRIOR TO THE BREAKAGE WITH THE WRIST STRAIGHTENED. THE SURGICAL STAFF DID NOT REPORT FEELING ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT OUT OF THE CANNULA. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1937031 DA VINCI ENERGY SYNCHROSEAL NAY INTUITIVE SURGICAL, INC 480440-06 L90211010 0231 10886874117306

    Patients

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