BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 16943359 · Received May 16, 2023

    Report

    Report Number
    2955842-2023-13675
    Event Type
    Malfunction
    Date Received
    May 16, 2023
    Date of Event
    April 14, 2023
    Report Date
    May 2, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    UDI-DI
    00886874116562
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE ENDOSCOPE WAS ANALYZED AND FOUND TO HAVE DAMAGED ATTACHED ENDOSCOPE ADAPTER (AEA) / FRICTION ISSUE, AND ENDOSCOPE BEARING FRICTION ISSUE.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE IMAGE ORIENTATION ISSUE, 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. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE ENDOSCOPE WAS NOT WORKING PROPERLY, WHEN THE CUSTOMER LOOKED LEFT, IT LOOKED RIGHT AND WHEN IT MOVED, IT GLITCHED. 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.

    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 SURGICAL PROCEDURE, THE 0-DEGREE ENDOSCOPE PLUS DID NOT WORK PROPERLY. WHEN THE CUSTOMER LOOKED LEFT, IT LOOKED RIGHT. WHEN IT MOVED, IT GLITCHED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) HAS MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1859971 NONE ENDOSCOPE GCJ INTUITIVE SURGICAL, INC 470056-08 N/A 00886874116562

    Patients

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