BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 16547657 · Received March 15, 2023

    Report

    Report Number
    2955842-2023-11313
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    February 17, 2023
    Report Date
    February 20, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874116555
    PMA / PMN Number
    K191736
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE 30-DEGREE ENDOSCOPE INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATIONS WAS ABLE TO CONFIRM THE REPORTED COMPLAINT BUT WAS NOT ABLE TO REPRODUCE THE ISSUE. FA FOUND THE ENDOSCOPE ADAPTER TO HAVE HAD A DAMAGE/FRICTION ISSUE. THE COMPLAINT REGARDING THE 30-DEGREE ENDOSCOPE REFLECTED A REVERSE IMAGE WAS CONFIRMED BY FA WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE OF THIS BINDING IS ATTRIBUTED TO COMPONENT SUSCEPTIBILITY TO INCREASED FRICTION. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: FAILURE ANALYSIS ACKNOWLEDGES THAT THE 30-DEGREE ENDOSCOPE WAS FOUND TO HAVE DAMAGE/FRICTION TO THE CAMERA INSTRUMENT ADAPTER (AEA) COMPONENT. DAMAGE/FRICTION TO THE CAMERA ADAPTER RESULTS IN POOR CAMERA CONTROL, WHICH COULD RESULT IN AN INVERTED IMAGE AND SUBSEQUENT TISSUE DAMAGE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SURGICAL PROCEDURE, THE 30-DEGREE ENDOSCOPE REFLECTED A REVERSED IMAGE. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY. THE SURGICAL PROCEDURE WAS NOT PROLONGED DUE TO THIS ISSUE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THE ENDOSCOPE MOVED IN NON-INTUITIVE MOTION. THE ENDOSCOPE WAS REPLACED TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758209 NONE ENDOSCOPE PLUS NAY INTUITIVE SURGICAL, INC 470057-08 N/A 00886874116555

    Patients

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