BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 17241167 · Received June 30, 2023

    Report

    Report Number
    2955842-2023-16727
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Date of Event
    June 6, 2023
    Report Date
    June 6, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING IMAGE ORIENTATION ISSUE, AN INVESTIGATION WAS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING FLIPPED ENDOSCOPE, 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 INSTRUMENT 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 THE ENDOSCOPE FLIPPING ISSUE WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER-REPORTED ISSUE. ADDITIONAL OBSERVATION(S) NOT REPORTED BY SITE: THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH MINOR CUT(S) TO THE CABLE INSULATION. THE DAMAGE WAS LOCATED IN ZONE B, MIDDLE 1/3 OF CABLE OF THE ENDOSCOPE CABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INCISIONAL HERNIA SURGICAL PROCEDURE, THE ARM MOVEMENT SEEMED OFF. WHEN THE CUSTOMER FLIPPED THE ENDOSCOPE FROM UP TO DOWN, IT WOULD NOT ROTATE ALL THE WAY. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE CUSTOMER TO REMOVE AND RE-ENGAGE THE ENDOSCOPE INTO ARM 2 AND ARM 3. THE TSE ASKED THE CUSTOMER TO TRY ANOTHER ENDOSCOPE IF POSSIBLE. THE SURGEON STATED THEY WERE SHORT ON ENDOSCOPES. THE TSE INFORMED THE CUSTOMER THAT THE ENDOSCOPE LIKELY NEED TO BE RETURNED FOR REPAIR. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ARM MOVED IN THE OPPOSITE DIRECTION WHEN THE SURGEON TRIED TO ROTATE. THERE WAS NO PATIENT 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
    1343904 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