BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI ENERGY

    MDR report key: 21089563 · Received January 7, 2025

    Report

    Report Number
    2955842-2025-00120
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    December 16, 2024
    Report Date
    December 16, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874117306
    PMA / PMN Number
    K191280
    Removal / Correction Number
    ISIFA2022-01-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER COMMENTED THAT THEY FELT AS IF THE FORCEPS MOVED WITH A DELAY AFTER THEY MOVED THEIR HAND. THE MOVEMENTS OF THE SURGEON DID SCALE APPROPRIATELY TO THE INSTRUMENT. THERE WAS NO PROBLEM WITH THE SCALE. THE INSTRUMENT MOVED IN THE INTENDED DIRECTION. THERE WAS A DELAY IN THE INSTRUMENT MOVEMENT. THERE WAS NO INJURY TO THE PATIENT AS RESULT OF THE EVENT. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OR ANYTHING OUT OF THE ORDINARY IDENTIFIED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE SYNCHROSEAL INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. THE REPORTED ISSUE WITH THE INSTRUMENT COULD NOT BE REPLICATED NOR CONFIRMED. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM AND PASSED THE RECOGNITION, SEAL AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVE WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSE PROPERLY. THERE WAS NO PHYSICAL DAMAGE ON THE SNAKE WRIST CABLES NOR MAIN TUBE OBSERVED DURING TESTING THAT WOULD HAVE CAUSED THE FAILURE. THE INSTRUMENT WAS FULLY FUNCTIONAL.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT FOR EVALUATION. HOWEVER, THE FAILURE ANALYSIS HAS NOT BEEN COMPLETED YET. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. .

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE SURGEON FELT A SLIGHT DISCOMFORT WITH THE MOVEMENT OF THE HAND CONTROL AND FORCEPS WHEN USING THE SYNCHROSEAL. THERE WAS NON-INTUITIVE MOTION WITH THE SYNCHROSEAL DURING THE OPERATION. THEY DESCRIBED THAT IT DID NOT MOVE INTENDEDLY. IT SEEMED AS IF THEY WERE SLIPPING OUT OF PLACE. AS A COUNTERMEASURE, THE SURGEON REMOVED AND REINSTALLED THE FORCEPS, BUT OVER TIME THE SLIPPAGE BEGAN TO OCCUR AGAIN. THE INSERTION AND REMOVAL WAS REPEATED ABOUT FOUR TIMES. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834263 DA VINCI ENERGY SYNCHROSEAL NAY INTUITIVE SURGICAL, INC 480440-06 0097 10886874117306

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES.