BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 17272226 · Received July 6, 2023

    Report

    Report Number
    2955842-2023-16849
    Event Type
    Malfunction
    Date Received
    July 6, 2023
    Date of Event
    June 14, 2023
    Report Date
    June 14, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING IMAGE ORIENTATION 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.

    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 REPORTED FAILURE WAS CONFIRMED. ADVANCED ENDOSCOPE ADAPTER (AEA) WAS FOUND TO BE DAMAGED OR FRICTION ISSUE WAS NOTED. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL HYSTERECTOMY SURGICAL PROCEDURE, THE ENDOSCOPE DID NOT ROTATE FROM THE SURGEON SIDE CONSOLE (SSC). THE CUSTOMER HAD TO RESEAT THE ENDOSCOPE TWICE AND HAD TO MOVE THE ENDOSCOPE ADAPTOR (AEA) MANUALLY. THE CUSTOMER INFORMED THAT EVEN ROTATING WITH THEIR HAND, THE AEA WAS ABNORMALLY HARD TO ROTATE. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE CUSTOMER TO STERILIZE THE ENDOSCOPE AND AEA AND TO ADVANCE EXCHANGE (AEX) IT AS SOON AS POSSIBLE. THE SYSTEM WAS READY FOR USE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ENDOSCOPE HAD INVERTED IMAGE DUE TO ENDOSCOPE NOT ROTATING. NO NON-INTUITIVE MOVEMENTS WERE OBSERVED. THE ENDOSCOPE WAS INSPECTED BEFORE USE. THERE WAS NOTING OUT OF THE ORDINARY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. THE PROCEDURE WAS COMPLETED USING SPARE ENDOSCOPE.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014938 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-08 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES