BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI

    MDR report key: 18213436 · Received November 27, 2023

    Report

    Report Number
    2955842-2023-20548
    Event Type
    Malfunction
    Date Received
    November 27, 2023
    Date of Event
    November 3, 2023
    Report Date
    November 3, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    UDI-DI
    00886874116555
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE STERILE ADAPTER WAS CORRECTLY SEATED. THE ISSUE OCCURRED ON THE 30 DEGREE ENDOSCOPE AND IT WAS INSTALLED IN DOWNWARD ORIENTATION. THE SURGEON CONFIRMED DESIRED ORIENTATION WHEN ENDOSCOPE WAS INSTALLED. NO INDICATION OF THE IMAGE ORIENTATION WAS PROVIDED TO THE USER VIA USER INTERFACE. THE ENDOSCOPE AND ENDOSCOPE¿S ADAPTER/BASE WERE STILL ENGAGED/IN-SYNCHRONIZATION/ATTACHED. THE ISSUE RESOLVED BY CALLING TECHNICAL SUPPORT AND USING ANOTHER ENDOSCOPE. THE VISION ISSUE DID NOT RESULT IN PATIENT INJURY. THE ENDOSCOPE WILL BE RETURNED TO ISI FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE CUSTOMER REINSTALLED THE ENDOSCOPE TO RESOLVE THE ISSUE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) RECOMMENDED REPLACING THE ENDOSCOPE IF THE ISSUE PERSISTED. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE ENDOSCOPE INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR 2 (USM) MADE AN UNEXPECTED MOVEMENT. PRIOR TO CALLING INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT, THE CUSTOMER REINSTALLED THE ENDOSCOPE AND THE ISSUE WAS CLEARED. THE TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LIVE LOGS, BUT NO RELEVANT SYSTEM ERRORS WERE PRESENT IN THE LIVE LOGS. THE TSE ASKED THE CUSTOMER TO CHECK THE PROPER SEATING OF THE STERILE ADAPTER AND MANUALLY ROTATE AND CHECK THE ENDOSCOPE FOR ANY GRINDING SOUNDS. THE CUSTOMER STATED THAT THE ISSUE SEEMED TO BE CLEARED AND AGREED TO CHECK THE ENDOSCOPE AFTER THE SURGERY. THE TSE RECOMMENDED THE CUSTOMER ON USING ANOTHER ENDOSCOPE IN CASE OF ISSUE RETURNED AND TO RETURN THE FAULTY ENDOSCOPE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537425 DA VINCI ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-08 N/A 00886874116555

    Patients

    Seq Age Sex Outcome Treatment
    1 Male DA VINCI INSTRUMENTS AND ACCESSORIES.