BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3612721 · Received February 7, 2014

    Report

    Report Number
    2955842-2014-00688
    Event Type
    Other
    Date Received
    February 7, 2014
    Date of Event
    January 10, 2014
    Report Date
    January 10, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2014, THE ISI FIELD SERVICE ENGINEER EVALUATED THE PSM ARM 2 AND DID NOT FIND ANY ISSUES; HOWEVER, THE PSM ARM 2 WAS REPLACED DUE TO THE CUSTOMER'S REPORTED COMPLAINT. THE DA VINCI SYSTEM WAS CHECKED AND VERIFIED TO BE WITHIN ISI SPECIFICATIONS. ON (B)(6) 2014, THE PSM ARM 2 INVOLVED WITH THE REPORTED COMPLAINT WAS EVALUATED BY ISI FAILURE ANALYSIS. THE REPORTED ISSUE WAS NOT REPLICATED; HOWEVER, INVESTIGATION NOTED THAT THE PSM ARM 2 FAILED THE BRAKE TEST. AS OF (B)(6) 2014, THE SITE HAS NOT HAD ANY RECURRING ISSUES WITH THE PSM ARM 2. THERE WAS NO REPORT OR ALLEGATION OF PATIENT INJURY; HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE DA VINCI SURGERY WAS CONVERTED TO AN OPEN SURGICAL PROCEDURE AFTER ENCOUNTERING RESISTANCE ISSUES WITH PSM ARM 2.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE SITE REPORTEDLY ENCOUNTERED ISSUES WITH THE PATIENT SIDE MANIPULATOR (PSM) ARM 2 DURING A DA VINCI PULMONARY LOBECTOMY PROCEDURE. THE SURGEON INFORMED THE REPORTER THAT WHEN HE WAS MOVING THE INSTRUMENTS IN OR OUT, THE MOVEMENT WAS NOT A SMOOTH GLIDING MOTION. THE SURGEON WOULD TRY TO PULL TOWARDS THE TISSUE, IT WOULD NOT MOVE, AND THEN IT WOULD HAVE A JABBING MOTION; HOWEVER, THE PATIENT DID NOT SUSTAIN ANY INJURIES. SHE CLAIMED THAT THE SURGICAL STAFF CHECKED THE PSM ARMS TO MAKE SURE THEY WERE NOT POSITIONED IN A WAY THAT WOULD CREATE RESISTANCE BETWEEN THE PSM'S. THE SURGEON DEALT WITH THE PSM RESISTANCE ISSUE WHILE DISSECTING TISSUE; HOWEVER, WHEN THE SURGEON WAS MOVING CLOSER TO VESSELS APPROXIMATELY 20-30 MINUTES INTO THE PROCEDURE, HE DECIDED TO CONVERT TO OPEN DUE TO THE PSM ARM 2 RESISTANCE ISSUE. THERE WERE NO REPORTED SURGICAL COMPLICATIONS OR PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79506 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000, A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other