BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 16456186 · Received February 28, 2023

    Report

    Report Number
    2955842-2023-10958
    Event Type
    Malfunction
    Date Received
    February 28, 2023
    Date of Event
    February 2, 2023
    Report Date
    February 2, 2023
    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
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE 30 DEGREE ENDOSCOPE INSTRUMENT INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED FOR EVALUATION. HOWEVER, THE FAILURE ANALYSIS INVESTIGATION HAS YET TO BE COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED POST ENGINEERING EVALUATION OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S COMPLAINT HISTORY INDICATES THAT THIS RECORD IS RELATED TO PATIENT IDENTIFIER (B)(6). A REVIEW OF THE INSTRUMENT LOGS FOR THE ENDOSCOPE INSTRUMENT (470027-62/SF1823016) ASSOCIATED WITH THIS EVENT WAS PERFORMED. THE INSTRUMENT WAS LAST USED ON (B)(6) 2022. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE ENDOSCOPE MOVED WITH UNINTUITIVE MOTION. POOR CAMERA CONTROL COULD RESULT IN UNINTUITIVE MOTION AND SUBSEQUENT TISSUE DAMAGE. AT THIS TIME, THE ROOT CAUSE OF THE FAILURE IS UNKNOWN. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVE THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE 8MM ENDOSCOPE,30 DEGREE WAS ANALYZED AND THE ENDOSCOPE WAS FOUND WITH DAMAGED AEA - CAMERA INSTRUMENT ADAPTER (CIAD) THIS CONFIRMS THE CUSTOMER REPORTED EVENT AND THE OBSERVATION IS ATTRIBUTED TO A COMPONENT FAILURE. ADDITIONALLY, FURTHER INSPECTION IDENTIFIED DAMAGE TO THE ENDOSCOPE ZONE C CABLE INTEGRITY, ENDOSCOPE BEARING FRICTION ISSUE AND MECHANICAL BUTTON DAMAGE. REVIEW OF THE LOGS CONFIRMED A TIMEOUT. THE ADDITIONAL OBSERVATIONS ARE UNRELATED AND THEY ARE INDICATIVE OF MISHANDLING AND MISUSE. THE ENDOSCOPE COULD NOT BE REPAIRED AND WAS SCRAPPED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA-BILATERAL SURGICAL PROCEDURE, CUSTOMER REPORTED THE ENDOSCOPE RECEIVED A 230003 ERROR AND IT HAD A FLIPPED ANGLE. 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 STATED IT WAS REPORTED THE 30-DEGREE ENDOSCOPE HAD AN UNINTENDED MOTION OF 180 DEGREES ROTATION. THE SURGEON WAS SUTURING MESH WHEN THE REPORTED ISSUE OCCURRED. THE REPORTER CONFIRMED THE IMAGE WAS INVERTED AND IT HAD UNCONTROLLED MOTION. THE EVENT DID NOT INVOLVE A REVERSED CONTROL ON SYSTEM ARMS. THE ROBOT FAULTED. SURGEON DID CONFIRM DESIRED ORIENTATION WHEN ENDOSCOPE WAS INSTALLED. THERE WAS AN INDICATION OF THE IMAGE ORIENTATION PROVIDED TO THE USER VIA USER INTERFACE. THE ENDOSCOPE AND THE ENDOSCOPE ADAPTER WERE STILL ENGAGED/ATTACHED. NO DAMAGE OBSERVED ON THE ENDOSCOPE. THE ENDOSCOPE WAS NOT MANUALLY ROTATED 180 DEGREES PRIOR TO EVENT. THE REPORTER STATED, THE FAULT HAD RECOVERED, AND THE SURGEON TURNED THE SCOPE 180 DEGREES AND FINISHED THE CASE. NO PATIENT HARM OR INJURY NOTED. IT HAS BEEN CONFIRMED THE ENDOSCOPE WILL BE RETURNED FOR ISI EVALUATION. THE REPORTER IS UNABLE TO PROVIDE THE PATIENT DEMOGRAPHIC OR THE PRODUCT INFORMATION DURING THIS TIME.

    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
    706864 NONE ENDOSCOPE NAY INTUITIVE SURGICAL, INC 470027-62 N/A

    Patients

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