BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 18760048 · Received February 22, 2024

    Report

    Report Number
    2955842-2024-11459
    Event Type
    Malfunction
    Date Received
    February 22, 2024
    Date of Event
    January 25, 2024
    Report Date
    January 25, 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
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. AS THE CUSTOMER WAS CALLING IN, THEY WERE ABLE TO GET THE ENDOSCOPE CORRECTED TO NOT BE UPSIDE DOWN. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) INFORMED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) ON HOW TO GET THE ENDOSCOPE ORIENTATION CORRECT THE NEXT TIME IT HAPPENS. THE TSE RECOMMENDED TO REPLACE THE ENDOSCOPE IF THEY HAD ANY ADDITIONAL ENDOSCOPE ERRORS. THE TSE ALSO SUGGESTED TO MANUALLY TEST THE ENDOSCOPE BEARINGS. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE APPEARED TO BE A USER ERROR AND WAS QUICKLY RESOLVED WITHOUT SIGNIFICANT DELAY OR ANY INJURY TO THE PATIENT. THE ISSUE WAS ADDRESSED WITH THE HELP OF ISI TECHNICAL SUPPORT PROVIDING TROUBLESHOOTING ASSISTANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY WEDGE RESECTION SURGICAL PROCEDURE, THE IMAGE WAS UPSIDE DOWN. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE LOGS AND FOUND ERROR 23003 ON AXIS 4 FOR THE ENDOSCOPE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    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
    1445006 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-11 N/A

    Patients

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