BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 2939795 · Received February 1, 2013

    Report

    Report Number
    2955842-2013-00333
    Event Type
    Injury
    Date Received
    February 1, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE CUSTOMER REPORTED FAILURE MODE WAS RELATED TO THE STERILE ADAPTER RELEASE TAB ON THE PATIENT SIDE MANIPULATOR ARM 1, WHICH PREVENTED SEATING OF THE STERILE ADAPTER ONTO THE PSM. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART, WHICH PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE STERILE ADAPTER RELEASE TAB IS LOCATED ON THE CARRIAGE OF THE PSM ARM AND HOLDS THE STERILE ADAPTER SECURELY IN PLACE ON THE PSM. THE STERILE ADAPTER PROVIDES THE ISOLATION BARRIERS TO ELECTRICAL CURRENT. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED PSM. THE PSM WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING CONFIRMED THE CUSTOMER REPORTED PROBLEM AND FOUND THAT THE WRIST OUTPUT ASSEMBLY POST HEIGHTS OF AXIS 4 THROUGH AXIS 7 ON THE PSM WERE OUT OF SPECIFICATION AND THE LINK 6 ON THE RELEASE TAB WAS BROKEN, THUS CAUSING THE ISSUE EXPERIENCED BY THE SITE. THE PSM WAS REPAIRED BY REPLACING THE AFFECTED OUTPUT ASSEMBLY POSTS AND RELEASE TAB. ENGINEERING EVALUATION ALSO FOUND THAT FOUR OF THE INNER POTENTIOMETERS WERE OUT OF SPECIFICATION FOR JITTER, BUT WERE OTHERWISE FUNCTIONING CORRECTLY. THE AFFECTED POTENTIOMETERS WERE ALSO REPLACED WHILE REPAIRING THE PSM. ON (B)(4) 2013, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) CONCERNING THE REPORTED EVENT. THE CSR ADVISED THAT THE SITE INDICATED TO HIM THAT THE URETER INJURY SUSTAINED BY THE PATIENT DURING THE DA VINCI S HYSTERECTOMY PROCEDURE WAS UNRELATED TO ANY MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORIES, BUT RATHER AN ERROR BY THE SURGEON OCCURRED. THE CSR ALSO INDICATED THAT THERE WAS NO REPORT BY THE SITE THAT ANY MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORIES OCCURRED DURING THE HYSTERECTOMY SURGICAL PROCEDURE THAT CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT. NO OTHER INFORMATION CONCERNING THE REPORTED EVENT WAS PROVIDED. AS OF (B)(4) 2013, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE PATIENT'S URETER WAS DAMAGED. DURING REPAIR OF THE PATIENT'S URETER BY THE SITE'S UROLOGIST, THE UROLOGIST NOTED THAT THE JAW ON THE ENDOWRIST INSTRUMENT INSTALLED ON THE PATIENT SIDE MANIPULATOR (PSM) ARM WAS NOT ARTICULATING CORRECTLY. REPORTEDLY, THE SITE REPLACED THE INSTRUMENTS MULTIPLE TIMES AND REPLACED THE DRAPE; HOWEVER, THE ISSUE PERSISTED. THE SITE REPORTED THAT DURING INSTALLATION OF THE STERILE ADAPTER ONTO THE PSM, IT WAS NOTED THAT THE STERILE ADAPTER DID NOT APPEAR TO ENGAGE FULLY WITH THE PSM. UNABLE TO RESOLVE THE ISSUE, THE SURGEONS MADE THE DECISION TO REPAIR PATIENT'S URETER AND COMPLETE THE SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44874 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A51.P7

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DA VINCI S SURG SYSTEM INSTRUMENTS & ACCESSORIES