BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 17067260 · Received June 5, 2023

    Report

    Report Number
    2955842-2023-15679
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Date of Event
    December 2, 2021
    Report Date
    December 2, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874116555
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE 30 DEGREE ENDOSCOPE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS DID NOT CONFIRM OR REPLICATE THE CUSTOMER REPORTED COMPLAINT. THE ENDOSCOPE WAS WORKING PROPERLY AND NO ISSUE WAS FOUND WITH ITS ORIENTATION. THERE WERE NO ERRORS AT THE QUALITY ASSURANCE PLAN (QAP) SYSTEM. NO RELATED ERRORS WERE FOUND IN THE LOGS. THERE WAS A GOOD IMAGE IN BOTH EYES. THERE WAS A RATTLE SOUND INSIDE INTEGRATED CONNECTOR (IC) HOUSING AND A SCOPE BEARING FRICTION ISSUE. THE ENDOSCOPE WAS RECEIVED WITH THE IC HOUSING BROKEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL VENTRAL HERNIA ETEP PROCEDURE, THE 30 DEGREE ENDOSCOPE HAD AN ERROR MESSAGE ANY TIME IT WAS FLIPPED FROM 30 UP TO 30 DOWN OR VICE VERSA. THE CLINICAL TERRITORY ASSOCIATE (CTA) CALLED A TECHNICAL SUPPORT ENGINEER (TSE) WHEN THE ISSUE PERSISTED AND REFERRED TO IT AS AN INVERTED VISION AND INSTRUMENT ENGAGEMENT ERROR 22020. THE CUSTOMER STATED THAT THEY HAD REMOVED AND RE-INSTALLED THE SCOPE AND THE ISSUE USUALLY CLEARED. THE LIVE LOGS WERE VIEWED BY THE TSE AND ERROR 22020 WAS NOTED ON THE 30 DEGREE ENDOSCOPE. THE CTA CONFIRMED THAT THERE WAS NO GRINDING HEARD. THE CUSTOMER WAS ASKED TO RETURN THE ENDOSCOPE FOR ANALYSIS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021279 NONE ENDOSCOPE PLUS NAY INTUITIVE SURGICAL, INC 470057-08 N/A 00886874116555

    Patients

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