BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 17122110 · Received June 13, 2023

    Report

    Report Number
    2955842-2023-16279
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Date of Event
    May 18, 2023
    Report Date
    May 18, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112212
    PMA / PMN Number
    K171426
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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 NEITHER REPLICATED NOR CONFIRMED. ADDITIONAL OBSERVATION NOT REPORTED BY SITE: 1. LASER MARKING ON NOSE HOUSING WAS FOUND TO BE DAMAGED. 2. SHELL HOUSING WAS FOUND TO BE DAMAGED. 3. 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 WERE CONFIRMED AS BINDING. THE ROOT CAUSE OF CAMERA INSTRUMENT ADAPTER ¿ BINDING IS DUE TO A COMPONENT FAILURE. THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE INITIAL REPORTER STATED THAT THE ISSUE OCCURRED DURING MITRAL VALVE REPAIR. THE IMAGE WAS INVERTED. THE 30-DEGREE ENDOSCOPE WAS INSTALLED AT TIME OF EVENT IN THE UP ORIENTATION. THE ORIENTATION WAS NOT CORRECT DUE TO CAMERA FLIPPING, THE ENDOSCOPE AND THE ENDOSCOPE¿S ADAPTER/BASE WERE STILL ENGAGED/IN-SYNCH/ATTACHED. THE SYSTEM RECOGNIZED THE CORRECT SCOPE. THE ENDOSCOPE WAS MANUALLY ROTATED 180-DEGREES WHEN IT WAS NEEDED. THE SURGEON MANUALLY ASSOCIATED THE RIGHT AND LEFT MASTERS WITH THE RESPECTIVE ARMS FOR INTUITIVE MOTION. THERE WAS NO PATIENT INJURY, AND THE PROCEDURE WAS COMPLETED WITH A BACKUP ENDOSCOPE. A SITE HISTORY REVIEW WAS PERFORMED AND FOUND A RELATED COMPLAINT UNDER PATIENT IDENTIFIER: (B)(6), IN WHICH ANOTHER SIMILAR INCIDENT OCCURRED WITH THE SAME ENDOSCOPE.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS NOT CONFIRMED. THE FSE TEST DROVE THE SYSTEM IN ACCORDANCE WITH ISI PROCEDURES AND COULD NOT FIND ANYTHING WRONG WITH THE SYSTEM OR THE SUSPECTED UNIVERSAL SURGICAL MANIPULATOR (USM). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE.

    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 MITRAL VALVE REPAIR SURGICAL PROCEDURE, THE CUSTOMER CALLED THE TECHNICAL SERVICE ENGINEER (TSE) AND STATED THAT THEY HAD INTERMITTENT ISSUE WITH ENDOSCOPE FLIPPING WHEN IT WAS INSTALLED. THE CUSTOMER WAS ABLE TO ROTATE THE ENDOSCOPE BACK TO THE CORRECT POSITION BUT WOULD LIKE THE SYSTEM LOOKED AT. THE CUSTOMER STATED THIS WAS AN ONGOING ISSUE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946317 NONE ENDOSCOPE NAY INTUITIVE SURGICAL, INC 470027-64 N/A 00886874112212

    Patients

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