BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 18778750 · Received February 26, 2024

    Report

    Report Number
    2955842-2024-11825
    Event Type
    Malfunction
    Date Received
    February 26, 2024
    Date of Event
    January 30, 2024
    Report Date
    January 30, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ALLEGED ISSUE OF INVERTED IMAGE DISPLAY ON ENDOSCOPE 1 IS DOCUMENTED THE REPORT SUBMITTED UNDER PATIENT IDENTIFIER 874186. THE ALLEGED ISSUE OF INVERTED IMAGE DISPLAY ON ENDOSCOPE 2 IS DOCUMENTED THE REPORT SUBMITTED UNDER PATIENT IDENTIFIER 881988. ISI HAS NOT RECEIVED THE PRODUCT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE INSTRUMENT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL SALVAGE PROSTATECTOMY SURGICAL PROCEDURE, THE 30-DEGREE ENDOSCOPE (ENDOSCOPE 1) DISPLAYED IMAGE ORIENTATION WAS INVERTED. SYSTEM DISPLAYED ERROR CODE 23003 AFTER TRYING TO ROTATE THE VIEW. THE CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). SYSTEM LOGS WERE REVIEWED AND NO ERROR FAULT WAS CONFIRMED. TSE ASKED THE CUSTOMER TO REMOVE THE ENDOSCOPE AND TO MOVE THE ENDOSCOPE ADAPTOR (AEA) WHERE A NOISE WAS PRESENT WHEN THE CUSTOMER TURNED IT. CUSTOMER WAS ADVISED TO REINSTALL THE ENDOSCOPE WITH THE FLAT PART OF THE ENDOSCOPE AS THE HORIZON GUIDE, BUT IT DID NOT WORK. SYSTEM LOGS WERE AGAIN REVIEWED AND ERROR CODE 31088 WAS PRESENT IN THE LOGS. THE CUSTOMER POWER CYCLED THE SYSTEM AND USED ANOTHER 30-DEGREE ENDOSCOPE (ENDOSCOPE 2) BUT THE ERROR FAULT PERSISTED. THERE WAS NO AUDIBLE NOISE PRESENT WHEN MANUALLY ROTATING THE AEA ON ENDOSCOPE 2. THE ERROR 23003 REMAINED PRESENT AFTER INSTALLING ENDOSCOPE 2 INTO ANOTHER UNIVERSAL SURGICAL MANIPULATOR (USM) ARM. A 0-DEGREE ENDOSCOPE (ENDOSCOPE 3) WAS INSTALLED AND NO FURTHER ISSUE WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2000615 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-11 N/A

    Patients

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