BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 17346982 · Received July 18, 2023

    Report

    Report Number
    2955842-2023-17137
    Event Type
    Malfunction
    Date Received
    July 18, 2023
    Date of Event
    June 20, 2023
    Report Date
    June 20, 2023
    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
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE 30-DEGREE ENDOSCOPE WAS ANALYZED AND FOUND WITH A DEFECTIVE CAMERA INSTRUMENT ADAPTER. THE FAILURE ANALYSIS INVESTIGATION PLACED THE 30-DEGREE ENDOSCOPE THROUGH A FRICTION TEST USING A SCREENING AIDE TO MANUALLY ROTATE THE ADAPTER TO DETECT FOR FRICTION. THE CAMERA INSTRUMENT ADAPTER DID NOT ROTATE PROPERLY DURING TESTING AND CONFIRMED AS BINDING. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING INVERTED IMAGE DISPLAY AND NON-INTUITIVE MOVEMENT, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. ISI HAS RECEIVED THE ENDOSCOPE INVOLVED WITH THIS COMPLAINT; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. THEREFORE, THE ROOT CAUSE OF THE ALLEGED CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED AFTER FAILURE ANALYSIS INVESTIGATION AND IF ADDITIONAL INFORMATION IS OBTAINED. ALTHOUGH THE COMPLAINT HAS NOT BEEN CONFIRMED BY FAILURE ANALYSIS SINCE THE INVESTIGATION IS IN PROGRESS. THE INFORMATION GATHERED INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE 30-DEGREE ENDOSCOPE COULD NOT BE MOVED UP AND DOWN. IT WAS FURTHER REPORTED THAT THE DISPLAYED IMAGE WAS INVERTED, AND THE ENDOSCOPE ALLEGEDLY MOVED NON-INTUITIVELY. ABNORMAL NOISE WAS ALSO OBSERVED. THE ENDOSCOPE WAS REMOVED. EXAMINATION OF THE BASE CONFIRMED THAT THE ENDOSCOPE WAS HARD TO ROTATE BY HAND. THE ISSUE WAS RESOLVED AFTER THE CUSTOMER RESEATED THE ENDOSCOPE. NO FURTHER ISSUE REPORTED. THE PROCEDURE WAS COMPLETED USING THE SAME ENDOSCOPE WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THAT THE REPORTED EVENT OCCURRED ON (B)(6) 2023. NO ADDITIONAL INFORMATION COULD BE PROVIDED REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829083 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