BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 18914115 · Received March 15, 2024

    Report

    Report Number
    2955842-2024-12316
    Event Type
    Malfunction
    Date Received
    March 15, 2024
    Date of Event
    February 19, 2024
    Report Date
    February 19, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K171426
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A RETURN MATERIAL AUTHORIZATION (RMA) WAS NOT ISSUED FOR RETURN. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA-UNILATERAL SURGICAL PROCEDURE, CUSTOMER REPORTED THE 30 DEGREE SCOPE IS FLIPPING WHEN THEY REINSTALL ON THE UNIVERSAL SURGICAL MANIPULATOR (USM). INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) WALKED CUSTOMER THROUGH RESETTING THE SCOPE POSITION BY AND REMOVE SCOPE FROM USM. TSE ADVISED THE CUSTOMER TO ROTATE ENDOSCOPE BASE UNTIL THE CORRECT ORIENTATION (30 UP OR 30 DOWN) IS DISPLAYED ON THE SCREEN, PRESS THE CLUTCH BUTTON ON THE USM THAT WAS HOLDING THE ENDOSCOPE (TO CANCEL GUIDED SCOPE CHANGE) AND REINSTALL THE ENDOSCOPE ONTO THE USM. CUSTOMER FOLLOWED THESE STEPS AND THIS RESOLVED THE ISSUE AND 30 DEGREE SCOPE REMAINED IN THE CORRECT ORIENTATION. TSE ALSO SAW A 23003 ERROR POINTING TOWARDS THE SCOPE BEARINGS IN THE LOGS. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER INDICATED IT WAS CONFIRMED THE PORTS HAD BEEN PLACED IN PATIENT. THE SURGICAL TASK THAT WAS BEING PERFORMED WAS AN INTRA-OPERATIVE PROCEDURE. THEY REMOVED THE CAMERA FOR CLEANING AND WHEN RE-INSERTING, IT FLIPPED TO THE OPPOSITE ORIENTATION. THE ENDOSCOPE WAS NOT CONFIRMED TO BE INVERTED. THERE WAS NO REVERSED CONTROL ON THE SYSTEM ARMS. THE VISION ORIENTATION CHANGE ON ITS OWN. THE ENDOSCOPE DID NOT MOVE FREELY WITH UNCONTROLLED MOTION. IT WAS THEN STATED THE SYSTEM RECOGNIZED THE CORRECT ENDOSCOPE. THE SURGEON DID CONFIRM DESIRED ORIENTATION WHEN ENDOSCOPE WAS INSTALLED. IT WAS CONFIRMED THAT THE INDICATION OF THE IMAGE ORIENTATION WAS PROVIDED TO THE SURGEON VIA USER INTERFACE. THE PROCEDURE WAS COMPLETED USING THE SAME ENDOSCOPE WITH THE BACKUP ENDOSCOPE ON STANDBY. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485628 NONE ENDOSCOPE NAY INTUITIVE SURGICAL, INC 470027-64 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES.