BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI ENERGY

    MDR report key: 17015645 · Received May 27, 2023

    Report

    Report Number
    2955842-2023-14774
    Event Type
    Injury
    Date Received
    May 27, 2023
    Date of Event
    July 23, 2020
    Report Date
    July 23, 2020
    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
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FAILURE ANALYSIS (FA) INVESTIGATIONS DID NOT CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS VISUALLY INSPECTED AND THERE WAS NO PHYSICAL DAMAGE FOUND OR BROKEN PIECES OBSERVED. THE FOREIGN MATERIAL RETURNED DID NOT APPEAR TO BELONG TO THE SILICONE SPRING PAD OF THE BOTTOM JAW. THE JAW CERAMIC DOTS WERE PRESENT AND A REVIEW OF THE SYSTEM LOGS SHOWED NO FAILURES. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE A TORN JAW COVER. TEARS MEASURED APPROXIMATELY 0.022" - 0.118" IN SIZE. NO MATERIAL WAS FOUND MISSING. A REVIEW OF THE SUBMITTED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE). THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: UPON INITIAL RECEIPT OF THE IMAGES, THE FAE WAS UNABLE TO INSPECT AREAS OF POTENTIAL DAMAGE WITHOUT MAGNIFICATION. THIS INSTRUMENT WAS TRANSFERRED TO ENGINEERING FOR FURTHER INVESTIGATION: THE INSTRUMENT SPRING PAD WAS INSPECTED UNDER HIGH MAGNIFICATION AND NO DAMAGE OR MISSING MATERIAL WAS FOUND. ADDITIONALLY, THE RETURNED FRAGMENT WAS INSPECTED UNDER HIGH MAGNIFICATION- IT DID NOT APPEAR TO ORIGINATE FROM THE SYNCHROSEAL. TO CONFIRM, A SPRING PAD WAS REMOVED FROM ANOTHER SYNCHROSEAL INSTRUMENT AS A CONTROL SAMPLE AND WAS RUN THROUGH FTIR. THE FTIR CORRECTLY DETECTED THE CONTROL SPRING PAD MATERIAL AS A TYPE OF SILICONE RUBBER. THE RETURNED FRAGMENT WAS RUN IN THE FTIR AND THE MATERIAL WAS MOST CLOSELY MATCHED AS POLYISOPRENE OR NATURAL RUBBER WITH A COMPLETELY DIFFERENT SPECTRAL WAVEFORM. THIS EVIDENCE CONFIRMS THE FRAGMENT DID NOT ORIGINATE FROM THE SYNCHROSEAL SPRING PAD AND LIKELY CAME FROM ANOTHER DEVICE. OTHER DAMAGE FOUND ON THE INSTRUMENT IS JAW COVER TEARS IN THE POUCH/TANG AREA OF THE JAW COVER. AN ISI FAE PERFORMED A REVIEW AND PROVIDED THE FOLLOWING RESULTS: THE FRAGMENT ITSELF WAS BLUE IN COLOR, AND WAS IDENTIFIED AS A TYPE OF NATURAL RUBBER. IT WAS FIRM IN TEXTURE, A LOT FIRMER THAN THE SILICONE IN THE SYNCHROSEAL SPRING PAD. IT COULD NOT HAVE COME FROM ANY OF THE OTHER INSTRUMENTS, AS THEY DO NOT CONTAIN ANYTHING SIMILAR IN MATERIAL MAKE-UP/COLOR TO THE RETURNED FRAGMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HIATAL HERNIA REPAIR SURGICAL PROCEDURE, PART OF THE BLUE SPRING PAD BROKE OFF OF THE SYNCHROSEAL INSTRUMENT JAW. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE AND WILL BE RETURNED TO ISI FOR ANALYSIS. THE BREAKAGE WAS NOTED DURING DISSECTION OF THE TISSUE NEAR THE CRUS. THE BROKEN FRAGMENT DID FALL INTO THE PATIENT AND WAS RETRIEVED AT THE TIME WITH A LAPAROSCOPIC NEEDLE DRIVER INSTRUMENT. THE SURGEON IS UNSURE AS TO WHAT CAUSED THE BREAKAGE. THE BREAKAGE WAS OBSERVED 15 MINUTES INTO USING THE SYNCHROSEAL INSTRUMENT. THE ADDITIONAL INSTRUMENT USED AT THE TIME OF THE PROCEDURE WAS A FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THE SYNCHROSEAL INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS DURING THE PROCEDURE, AND THE WRIST WAS STRAIGHTENED PRIOR TO REMOVAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1849828 DA VINCI ENERGY SYNCHROSEAL NAY INTUITIVE SURGICAL, INC 480440-05 T90200130 0136 10886874117306

    Patients

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