BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 21682391 · Received March 24, 2025

    Report

    Report Number
    2955842-2025-11240
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Date of Event
    February 26, 2025
    Report Date
    February 27, 2025
    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
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE 30-DEGREE ENDOSCOPE PLUS TO PERFORM FAILURE ANALYSIS (FA). FA WAS ABLE TO CONFIRM THE REPORTED COMPLAINT VIA SYSTEM LOGS BUT WAS NOT ABLE TO REPRODUCE THE ISSUE DURING IN-HOUSE TESTING. ADDITIONAL OBSERVATION NOT REPORTED BY SITE: THE ENDOSCOPE WAS DISASSEMBLED, AND THE CAMERA MODULE WAS VISUALLY INSPECTED AND PLACED ON AN INTERNAL TESTER AND FAILED. THE CAMERA MODULE FAILED THE NO IMAGE TEST.

    Additional Manufacturer Narrative · 0

    THE 30-DEGREE ENDOSCOPE PLUS INVOLVED WITH THIS EVENT HAS BEEN RECEIVED, BUT THE FAILURE ANALYSIS TESTING HAS NOT YET BEEN COMPLETED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 30-DEGREE ENDOSCOPE PLUS WAS BROKEN BUT NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER STATED THERE WAS NO PHYSICAL DAMAGE TO THE SCOPE. HOWEVER, THE OPERATING ROOM TEAM REPORTED THAT THE IMAGE DID NOT DISPLAY CORRECTLY, AND WHEN IT DID, THE ORIENTATION WAS INVERTED WITH NO OPTION TO ADJUST IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754223 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-12 N/A 00886874116555

    Patients

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