BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 3358983 · Received September 19, 2013

    Report

    Report Number
    2955842-2013-03707
    Event Type
    Other
    Date Received
    September 19, 2013
    Date of Event
    August 21, 2013
    Report Date
    August 21, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K021036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION CAN BE FOUND. ON 03/31/2014, INTUITIVE SURGICAL, INC. (ISI) OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ON (B)(6) 2013, THE PATIENT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE. THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGICAL TECHNIQUES APPROXIMATELY 30 MINUTES AFTER THE DA VINCI PROSTATECTOMY PROCEDURE WAS STARTED. THE PATIENT DID NOT EXPERIENCE ANY INTRA-OPERATIVE OR POST-OPERATIVE COMPLICATIONS. THE REPORTED ISSUE WITH PSM WAS RESOLVED.

    Additional Manufacturer Narrative · 1

    THE PSM WAS RETURNED TO ISI AND EVALUATED BY FAILURE ANALYSIS (FA). FA WAS ABLE TO CONFIRM THE FIELD REPORTED COMPLAINT OF LOW CABLE TENSION ON INSERTION CABLES USING GAGE TEST. THE PSM PASSED ALL FUNCTIONAL TESTS UNRELATED TO CABLE TENSION. INTUITIVE SURGICAL INC. (ISI) HAS ATTEMPTED TO CONTACT THE INITIAL REPORTER OF THIS COMPLAINT TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGICAL STAFF ENCOUNTERED NON-INTUITIVE MOVEMENT OF A PSM AND THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI SURGICAL PROCEDURE TO OPEN SURGICAL TECHNIQUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SURGICAL PROCEDURE, THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGIRICAL TECHNIQUES AFTER ENCOUNTERING A NON-INTUITIVE MOTION ISSUE WITH PATIENT SIDE MANIPULATOR 2 (PSM2). THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. THE INITIAL REPORTER INDICATED THAT CABLE 1 AND 2 ON PSM2 HAD LOW TENSION. THE INITIAL REPORTER REPAIRED THE SYSTEM BY REPLACING THE PSM. NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472281 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS1200 A4.3P9

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI SURGICAL SYSTEM, INSTRUMENTS, ACCESSORIE