BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 16811372 · Received April 25, 2023

    Report

    Report Number
    2955842-2023-12175
    Event Type
    Malfunction
    Date Received
    April 25, 2023
    Date of Event
    March 23, 2023
    Report Date
    March 28, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    UDI-DI
    00886874116555
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE 30-DEGREE ENDOSCOPE PLUS ASSEMBLY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED THE CUSTOMER REPORTED COMPLAINT ¿ROTATION ASSEMBLY OF THE ENDOSCOPE WAS STIFF¿ AND THAT THE CAMERA WOULD PARTIALLY ROTATE WHEN ADVANCED. THE 30-DEGREE ENDOSCOPE PLUS WAS ANALYZED AND FOUND TO HAVE AN ENDOSCOPE ADAPTER DAMAGED OR FRICTION ISSUE. THERE WAS 5000 DELAMINATION AND AN ENDOSCOPE BEARING FRICTION ISSUE. THE COMPLAINT REGARDING THE ENDOSCOPE WAS STIFF WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATED THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ROTATION ISSUE. AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. THIS COMPLAINT IS REPORTABLE MALFUNCTION EVENT, DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE ENDOSCOPE MOVED FREELY WITH UNCONTROLLED MOTIONS WHEN BEING ADVANCED. 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 RADICAL CYSTECTOMY SURGICAL PROCEDURE, THE ENDOSCOPE ROTATION ASSEMBLY WAS STIFF. THE CAMERA WOULD PARTIALLY ROTATE WHEN ADVANCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539873 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-08 N/A 00886874116555

    Patients

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