BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 17067243 · Received June 5, 2023

    Report

    Report Number
    2955842-2023-15670
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Date of Event
    August 26, 2022
    Report Date
    August 26, 2022
    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
    NO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ENDOSCOPE INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS FOUND BINDING TO THE ATTACHED ENDOSCOPE ADAPTER (AEA). IN ADDITION, THE ENDOSCOPE WAS FOUND TO HAVE STRAIN RELIEF ON THE INTEGRATED CONNECTOR (IC) HOUSING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL EXTRAPERITONEAL WITH LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, THE SURGEON FLIPPED THE ENDOSCOPE FROM DOWN TO UP, BUT THE ENDOSCOPE DID NOT PHYSICALLY ROTATE. THUS, THEY WERE HAVING INVERTED IMAGE AND INVERTED INSTRUMENT MOVEMENTS. THEY SOLVED THE ISSUE BY REMOVING THE ENDOSCOPE, ROTATING IT MANUALLY AND REINSERTING IT AGAIN. AFTER DOING SO, THEY CONTINUED WITH THE PROCEDURE AS PLANNED. THE CUSTOMER INQUIRED ABOUT HOW THE ISSUE HAD OCCURRED. THE INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE ERROR LOGS, BUT THERE WERE NOT ANY ENGAGEMENT ERRORS ASSOCIATED WITH AN IMPROPERLY SEATED STERILE ADAPTER OR ENDOSCOPE ENGAGEMENT. THE TSE ASKED THE CALLER WHETHER THEY COULD HEAR ANY UNUSUAL NOISE WHEN ROTATING THE ENDOSCOPE MANUALLY, WHICH THE CALLER STATED THEY WOULD VERIFY WHEN CLINICALLY POSSIBLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020449 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-08 N/A 00886874116555

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES