BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 17300110 · Received July 11, 2023

    Report

    Report Number
    2955842-2023-16949
    Event Type
    Malfunction
    Date Received
    July 11, 2023
    Date of Event
    June 14, 2023
    Report Date
    June 14, 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
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ENDOSCOPE'S NON-INTUITIVE MOTION, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE CONFIRMED THE REPORTED COMPLAINT. THE BASE OF THE HOUSING OF THE 30-DEGREE ENDOSCOPE WAS STIFF AND DIFFICULT TO ROTATE. THE FSE REPLACED THE 30-DEGREE ENDOSCOPE TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE 30-DEGREE ENDOSCOPE WAS ANALYZED AND FOUND TO HAVE A DEFECTIVE CAMERA INSTRUMENT ADAPTER. THE ENDOSCOPE WAS PLACED THROUGH FRICTION TEST USING A SCREENING AIDE TO MANUALLY ROTATE THE ADAPTER TO DETECT FOR FRICTION. THE CAMERA INSTRUMENT ADAPTER DID NOT ROTATE PROPERLY, AND NOISE WAS HEARD DURING TESTING AND CONFIRMED AS BINDING. THE COMPLAINT REGARDING THE NON-INTUITIVE MOTION WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. ADDITIONAL OBSERVATION NOT RELATED TO THE REPORTED ISSUE WAS ALSO FOUND: THE ENDOSCOPE HAD MECHANICAL DAMAGE ON THE LIGHT GUIDE FERRULE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE 30-DEGREE ENDOSCOPE ROTATED 180 DEGREES AND MOVED NON-INTUITIVELY. THE CUSTOMER USED 0-DEGREE ENDOSCOPE TO CONTINUE THE PROCEDURE WITH NO FURTHER ISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. AFTER THE PROCEDURE, THE 30-DEGREE ENDOSCOPE ROTATED ONLY A HALFWAY UP AND DOWN AND DID NOT MOVE AS INTENDED WHEN IT WAS TESTED. AN INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER ATTEMPTED TO INVERT THE IMAGE BY PRESSING UP/DOWN BUTTON, BUT THE INVERSION WAS INSUFFICIENT. WHEN THE ENDOSCOPE WAS INSTALLED ON THE UNIVERSAL SURGICAL MANIPULATOR, THE ENDOSCOPE ROTATED WITHOUT CONTROL. NO DAMAGE WAS OBSERVED ON THE ENDOSCOPE ADAPTER/BASE. THE ISSUE DID NOT RESULT IN PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1922889 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-08 N/A 00886874116555

    Patients

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