BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 17244954 · Received July 3, 2023

    Report

    Report Number
    2955842-2023-16772
    Event Type
    Malfunction
    Date Received
    July 3, 2023
    Date of Event
    May 25, 2023
    Report Date
    June 7, 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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING UNINTUITIVE MOTION, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE ENDOSCOPE PLUS 30-DEGREE WAS ANALYZED AND FOUND TO HAVE A CAMERA INSTRUMENT ADAPTER DEFECT. THE ENDOSCOPE WAS PLACED THROUGH A FRICTION TEST USING A SCREENING AIDE TO MANUALLY ROTATE THE ADAPTER TO DETECT FRICTION. THE CAMERA INSTRUMENT ADAPTER DID NOT ROTATE PROPERLY AND/OR NOISES WERE HEARD DURING TESTING AND CONFIRMED AS BINDING. THE COMPLAINT REGARDING NON-INTUITIVE MOTION WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER-REPORTED ISSUE. ADDITIONAL OBSERVATION NOT REPORTED BY SITE: THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH COSMETIC DAMAGE. DURING AN INSPECTION OF THE ENDOSCOPE CABLE INTEGRATED CONNECTOR, THE CONNECTOR EXHIBITED DISCOLORATION. A VISUAL INSPECTION CONFIRMED DISCOLORATION OF THE HOUSING.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE 30-DEGREE ENDOSCOPE WAS HAVING ROTATION ISSUE AND THE SCOPE MOVED FREELY WITH UNCONTROLLED MOTION, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. A RETURN MATERIAL AUTHORIZATION (RMA) HAS BEEN ISSUED AND INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED TO HAVE THE 30-DEGREE ENDOSCOPE INSTRUMENT BE RETURNED FOR EVALUATION; HOWEVER, THE PRODUCT HAS NOT YET BEEN RECEIVED AS OF THE DATE OF THIS REPORT. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED.

    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 CHOLECYSTECTOMY SURGICAL PROCEDURE, THE ROTATION OF THE 30-DEGREE ENDOSCOPE WAS VERY STIFF, AND THE CAMERA TENDED TO ROTATE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS REPORTED THE SURGICAL TASK THAT WAS BEING PERFORMED WAS THE CHOLECYSTECTOMY. THE REPORTER INDICATED THE SURGEON HAD THE ENDOSCOPE AT A 30 DEGREE DOWN AND IT WOULD ROTATE TO A 45-DEGREE ANGLE AS THE INSTRUMENT ADVANCED. THE ENDOSCOPE WAS CONFIRMED TO MOVE FREELY WITH UNCONTROLLED MOTION. THE 30-DEGREE ENDOSCOPE WAS INSTALLED A DOWN ORIENTATION. THE SURGEON CONFIRMED THE DESIRED ORIENTATION WHEN THE ENDOSCOPE WAS INSTALLED. IT WAS UNKNOWN IF THE IMAGE ORIENTATION PROVIDED TO THE USER VIA USER INTERFACE. THE ENDOSCOPE ADAPTER WAS STILL ENGAGED/ATTACHED. THERE WAS NO DAMAGE OBSERVED ON THE ENDOSCOPE ADAPTER. PRIOR TO THE EVENT THE ENDOSCOPE MANUALLY ROTATED 180 DEGREES. THE SURGEON MANUALLY ASSOCIATED THE RIGHT AND LEFT MASTERS WITH RESPECTIVE ARM FOR INTUITIVE MOTION. THEY USED A BACKUP ENDOSCOPE TO RESOLVE THE ISSUE. NO PATIENT HARM OR INJURY. THE ENDOSCOPE WILL BE RETURNED FOR ISI EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344154 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