BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 18646303 · Received February 5, 2024

    Report

    Report Number
    2955842-2024-11016
    Event Type
    Malfunction
    Date Received
    February 5, 2024
    Date of Event
    January 11, 2024
    Report Date
    January 11, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110690
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE TECHNICAL SERVICE ENGINEER (TSE) ADVISED THE CUSTOMER TO REPLACE THE SA ON PSM2. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INSTRUMENT TIP ON PATIENT SURGICAL MANIPULATOR (PSM)2 RETURNED TO BEING STRAIGHT WHEN THE SURGEON HAD THE WRIST BENT UPWARD. THE SURGEON RESEATED THE STERILE ADAPTER (SA) AND INSTRUMENT, BUT IT DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. THE SURGEON'S HEAD WAS INSIDE THE HIGH-RESOLUTION STEREO VIEWER WHILE ATTEMPTING TO MANIPULATE THE INSTRUMENTS. THE FAILURE WAS NOT RELATED TO THE INABILITY TO MOVE THE INSTRUMENT. THE INSTRUMENT SCALED APPROPRIATELY, HAD APPROPRIATE TIMING, AND MOVED IN THE INTENDED DIRECTION. HOWEVER, THERE WAS SHAKINESS/FRICTION EXPERIENCED PERSISTENTLY. THERE WAS NO INSTRUMENT-TO-INSTRUMENT INTERFERENCE. THE SURGEON WAS PEELING AT THE LEFT SIDE OF THE PATIENT APPROXIMATELY 1.5 TO 2 HOURS AFTER THE START OF THE SURGICAL PROCEDURE WHEN THE ISSUE OCCURRED. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503280 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-11 N/A 00886874110690

    Patients

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