BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 18744145 · Received February 20, 2024

    Report

    Report Number
    2955842-2024-11190
    Event Type
    Malfunction
    Date Received
    February 20, 2024
    Date of Event
    January 26, 2024
    Report Date
    January 26, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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. THE FSE REPLACED THE E-100 GENERATOR TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE GENERATOR FOR EVALUATION AND THE REPORTED FAILURE WAS REPLICATED. THE UNIT WAS INSTALLED ONTO THE TEST SYSTEM AND FAILED TESTING. THE POWER LED TURNED RED AND BIPOLAR LED DID NOT TURN ON, CANNOT CUT/SEAL. A REVIEW OF A PROVIDED IMAGE WAS PERFORMED BY AN ISI CLINICAL DEVELOPMENT ENGINEER (CDE). THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE POWER BUTTON AND LED ON THE E-100 APPEARS TO BE SOLID RED IN THE IMAGE WHICH INDICATES (REFERENCE TO THE E-100 USER MANUAL) THAT THE E-100 IS IN A FAULTED STATE. BASED ON THE IMAGE ALONE WE CANNOT DETERMINE WHAT LEAD TO THE FAULT. IF THE E-100 FAULT IS NOT RESOLVED WITH A POWER CYCLE, WE WOULD RECOMMEND THE CUSTOMER CONTACT FIELD SERVICE ENGINEERING FOR POTENTIAL SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED OOPHORECTOMY SURGICAL PROCEDURE, THE VESSEL SEALER EXTEND (VSE) INSTRUMENT DID NOT WORK IN THE E-100 GENERATOR. THE CUSTOMER MOVED THE INSTRUMENT TO THE ERBE INTEGRATED ELECTRO SURGICAL UNIT (IESU) TO CONTINUE. THE CUSTOMER STATED THAT THERE WERE NO MESSAGES DISPLAYED WHEN CONNECTING THE VSE INSTRUMENT TO THE E-100 AND STATED THAT THE E-100 POWER BUTTON AND LED WERE RED. 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 SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM. THE MACHINE WAS POWERED ON, AND THE LIGHT WAS RED ONCE THE MACHINE WAS TURNED ON. THE INSTRUMENT DID NOT INITIALLY POWER ON WITHOUT ERRORS. ALSO, THE LIGHT WAS RED, AND IT DID NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426597 N/A N/A NAY INTUITIVE SURGICAL, INC 374848-09 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES.