BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 19756689 · Received July 16, 2024

    Report

    Report Number
    2955842-2024-16920
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    June 21, 2024
    Report Date
    June 21, 2024
    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
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE 30 DEGREE ENDOSCOPE WAS EVALUATED AND PLACED ON A DIAGNOSTIC TESTER OR EQUIVALENT FOR FUNCTIONAL TESTING. THE LIGHT LEAKAGE TEST WAS PERFORMED TO DETECT IF ANY IMAGE QUALITY DEFECTS WERE DETECTED IN EITHER OR BOTH EYES. THE ENDOSCOPE WAS FOUND WITH AN ARTIFACT(S) IN THE LEFT EYE. THE ENDOSCOPE WAS EVALUATED AND FOUND WITH A CAMERA INSTRUMENT ADAPTER DEFECT. THE ENDOSCOPE WAS PLACED 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 AND/OR NOISES WERE HEARD DURING TESTING AND CONFIRMED AS BINDING. THE CAMERA INSTRUMENT ADAPTER WAS REMOVED FROM THE ENDOSCOPE HOUSING AND EVALUATED AND FOUND WITH AN ATTACHED ENDOSCOPE ADAPTER (AEA) SHAFT BEARING CONTRIBUTING TO FRICTION. ADDITIONALLY, THE ENDOSCOPE WAS DISASSEMBLED AND THE CAMERA MODULE WAS VISUALLY INSPECTED AND PLACED ON AN INTERNAL TESTER AND FAILED. THE CAMERA MODULE FAILED THE MTF TEST. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) HAS RECEIVED THE ENDOSCOPE INVOLVED WITH THE EVENT; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE 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 RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE USER OBSERVED AN ISSUE WITH THE ENDOSCOPE AND ITS IMAGE ORIENTATION FUNCTIONALITY. BASED ON THE INFORMATION, THE IMAGE ORIENTATION AND HORIZON LINE ON THE ENDOSCOPE THAT WAS INSTALLED ON UNIVERSAL SIDE MANIPULATOR (USM) 3 WAS OFF. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). THE TSE INSTRUCTED USER TO REMOVE ENDOSCOPE FROM THE USM, ROTATE ENDOSCOPE BASE UNTIL THE CORRECT ORIENTATION (30 UP OR 30 DOWN) WAS DISPLAYED ON THE SCREEN. PRESS THE CLUTCH BUTTON ON THE USM THAT WAS HOLDING THE ENDOSCOPE (TO CANCEL GUIDED SCOPE CHANGE). REINSTALL THE ENDOSCOPE ONTO THE USM. CUSTOMER FOLLOWED THESE STEPS AND REINSTALLED THE ENDOSCOPE BACK ONTO USM 3. FOLLOWING THIS, THE CUSTOMER STATED THAT THE IMAGE LOOKED GOOD. THE USER CONTINUED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2504376 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-11 N/A 00886874116555

    Patients

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