BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 20325653 · Received September 27, 2024

    Report

    Report Number
    2955842-2024-19849
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    September 4, 2024
    Report Date
    September 4, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874116555
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS ISSUED A RETURN MATERIAL AUTHORIZATION (RMA) TO HAVE THE INTUITIVE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE PRODUCT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS AND THE COMPLAINT WAS CONFIRMED. FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE ENDOSCOPE WAS PLACED THROUGH FRICTION TEST USING A SCREENING AID TO MANUALLY ROTATE THE ADAPTER TO DETECT FOR FRICTION. THE CAMERA INSTRUMENT ADAPTER DID NOT ROTATE PROPERLY AND/OR NOISES WERE HEARD DURING TESTING AND CONFIRMED AS BINDING. ADDITIONAL OBSERVATIONS FOUND UNRELATED TO THE REPORTED COMPLAINT INCLUDED: THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH COSMETIC DAMAGE. DURING INSPECTION, THE CABLE INTEGRATED CONNECTOR HOUSING EXHIBITED DISCOLORATION. THE ENDOSCOPE ALSO HAD MINOR CUTS TO THE CABLE INSULATION. THE DAMAGE WAS LOCATED AT ZONE B IN THE MIDDLE 1/3 ON THE ENDOSCOPE CABLE. FURTHER, THE ENDOSCOPE WAS EVALUATED AND FOUND WITH A CAMERA INSTRUMENT ADAPTER DEFECT. THE CAMERA INSTRUMENT ADAPTER REMOVED FROM ENDOSCOPE HOUSING AND EVALUATED AND FOUND WITH ATTACHED ENDOSCOPE ADAPTER (AEA) SHAFT BEARING CONTRIBUTING TO FRICTION. THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH MECHANICAL DAMAGE ON THE ENDOSCOPE¿S SHAFT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON FELT MOVEMENT SEEMED TO BE A LITTLE OFF AND NOT INTUITIVE ON THE UNIVERSAL SURGICAL MANIPULATOR (USM). THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND DID NOT FIND ANY RELATED ERRORS. THE CUSTOMER WAS GOING TO REPLACE THE ENDOSCOPE TO SOLVE THE ISSUE. THE SURGEON STATED THAT MOVEMENT ON ALL USMS WAS NOT INTUITIVE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THE ISSUE WAS RELATED TO THE ENDOSCOPE AND NOT THE SYSTEM. THE ENDOSCOPE WITH THE MOTION ISSUE WAS THE 30-DEGREE ENDOSCOPE 470057-08, SERIAL # (B)(6). THE ENDOSCOPE MOVED FREELY WITH UNCONTROLLED MOTION. THE SURGEON STATED THAT WHEN HE POINTED THE ENDOSCOPE AT AN OBJECT, THE IMAGE JUMPED TO A DIFFERENT POSITION. THE SURGEON CONFIRMED THE DESIRED ORIENTATION WHEN THE ENDOSCOPE WAS INSTALLED. THE ENDOSCOPE AND ENDOSCOPE¿S ADAPTER/BASE WERE STILL ENGAGED/IN-SYNCH/ATTACHED. THERE WAS NO DAMAGE OBSERVED ON THE ENDOSCOPE¿S ADAPTER/BASE SUCH AS A MISSING SCREW(S) OR COMPONENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP ENDOSCOPE. THE VISION ISSUE DID NOT RESULT IN PATIENT INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1663906 NONE ENDOSCOPE PLUS NAY INTUITIVE SURGICAL, INC 470057-08 N/A 00886874116555

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES.