BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI ENERGY

    MDR report key: 20082395 · Received August 27, 2024

    Report

    Report Number
    2955842-2024-18723
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    August 1, 2024
    Report Date
    August 2, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119051
    PMA / PMN Number
    K191280
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE E-100 GENERATOR, BUT FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED AFTER FAILURE ANALYSIS INVESTIGATION AND IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 0

    THE E-100 GENERATOR WAS RETURNED AND ANALYZED AND FOUND TO HAVE NO FAILURES. THIS UNIT WAS INSTALLED ONTO THE TEST SYSTEM AND MANUALLY POWER CYCLED 10 TIMES. THE E-100 POWERED ON WITH NO ISSUE EACH TIME. THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS INSTALLED ONTO UNIT WITH A SALINE DIPPED GAUZE IN THE JAWS. THE E-100 WAS FIRED WITH YELLOW PEDAL/SYNC ACTIVATION AND CUT/SEAL ABOUT 100 TIMES. THE UNIT WORKED FINE WITHOUT ANY ISSUE. THE COMPLAINT WAS NOT CONFIRMED BASED ON THE FIELD EVALUATION/FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CALLED IN OFF SITE TO REPORT THAT THEY WERE CONTACTED BY THE SURGEON WHO EXPLAINED E-100 GENERATOR DID NOT WORK. THE CSR EXPLAINED THAT SURGEON IS REALLY EXPERIENCED AND TRIED REBOOTING AND CHECKING CABLING WITH NO IMPROVEMENT. THE CSR EXPLAINED THAT THEY COULD HEAR A SOUND BUT THERE WAS NO ENERGY COMING OUT OF THE GENERATOR. ISI FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE E-100 DIDN'T WORK. THE VESSEL SEALER EXTEND (VSE) WAS INSERTED INTO THE INTEGRATED ELECTROSURGICAL UNIT (IESU), ALLOWING THE CASE TO CONTINUE. THE IESU WAS USED, AND THE ISSUE WAS REPORTED TO DVSTAT AND RESOLVED BY REPLACING THE E-100 GENERATOR WITH THE FIELD SERVICE ENGINEER (FSE). THERE WERE NO INJURIES TO THE PATIENT, AND THE OPERATION WAS NOT DELAYED.

    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
    1495128 DA VINCI ENERGY E-100 GENERATOR NAY INTUITIVE SURGICAL, INC 378848 N/A 00886874119051

    Patients

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