BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI ENERGY

    MDR report key: 12679655 · Received October 22, 2021

    Report

    Report Number
    2955842-2021-11344
    Event Type
    Malfunction
    Date Received
    October 22, 2021
    Date of Event
    September 26, 2021
    Report Date
    September 26, 2021
    Product Code
    NAY
    UDI-DI
    10886874117306
    PMA / PMN Number
    K191280
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE SYNCHROSEAL INSTRUMENT FOR EVALUATION BECAUSE THE INSTRUMENT WAS DISPOSED BY THE SITE. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. IN ADDITION, A REVIEW OF THE INSTRUMENT LOG FOR THE SYNCHROSEAL INSTRUMENT (PART # 480440-05/ LOT # L90210221 0077) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS USED ON (B)(6) 2021, ON SYSTEM (B)(4). THIS IS A SINGLE-USE INSTRUMENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED TO ISI FOR REVIEW. THIS EVENT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE INSTRUMENT MAY HAVE ARCED DURING THE PROCEDURE WITH NO EVIDENCE OR CLAIM OF USER MISHANDLING OR MISUSE. THE ALLEGATION IS RELATED TO THE POTENTIAL FOR ELECTRICAL DISCHARGE AT A LOCATION OTHER THAN INTENDED. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CLINICAL SALES REPRESENTATIVE (CSR) CALLED IN STATING THAT THE E-100 GENERATOR POWERED OFF WHILE USING A SYNCHROSEAL INSTRUMENT. THE E-100 GENERATOR WAS POWERED ON AGAIN, AND THE ISSUE WAS RESOLVED. THE CSR FOUND NO DAMAGE ON THE SYNCHROSEAL ¿S JAW. THE SUSPECTED CAUSE OF THE ISSUE WAS DUE TO ARCING. THE PROCEDURE WAS CONTINUING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYNCHROSEAL INSTRUMENT WAS VISUALLY INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. THE INSTRUMENT WORKED FOR ABOUT 3 TO 4 HOURS AND SEALED TISSUE AT THE TIME OF THE EVENT. IT DISPLAYED SYNC MODE WHEN SEALED AND THE JAW WAS CLOSED. WHEN THE SURGEON PRESSED THE YELLOW PEDAL AGAIN, THE MESSAGE "CHECK THAT E-100 IS POWERED ON, E-100 NOT DETECTED¿ DISPLAYED, AND THE SURGEON NOTICED THE POWER WAS OFF. IT WAS UNKNOWN IF ARCING WAS OBSERVED AND IF ARCING DID HAPPEN, IF IT WAS CONTAINED WITHIN THE JAWS OF THE INSTRUMENT. THE JAWS DID NOT COME INTO CONTACT WITH A CLIP, SUTURE, STAPLE, OR OTHER METAL OBJECTS. FOR VASCULAR TREATMENT, THE MEDIUM-LARGE CLIP WAS USED IN THE CENTER WHILE THE SYNCHROSEAL WAS USED FOR THE PERIPHERY. THE SYNCHROSEAL WAS KEPT AWAY FROM THE CLIP. THE JAWS WERE NOT IMMERSED IN A LIQUID OR CONTAMINATED BY CARBONIZED TISSUE (BIO DEBRIS) PRIOR TO OR DURING THE SEALING CYCLE. THE INSTRUMENT WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. PHOTOGRAPHIC IMAGES OF THE DEVICE OR A VIDEO RECORDING OF THE PROCEDURE WERE NOT AVAILABLE FOR ISI REVIEW. INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY WERE REQUESTED; HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1583487 DA VINCI ENERGY SYNCHROSEAL NAY 480440-05 L90210221 0077 10886874117306

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI INSTRUMENTS AND ACCESSORIES