BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 2912030 · Received January 11, 2013

    Report

    Report Number
    2955842-2013-00150
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K070684
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2013, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE WHO WAS PRESENT DURING THE PLANNED SURGICAL PROCEDURE. THE CSR INDICATED THAT THE SURGEON UTILIZED TRADITIONAL LAPAROSCOPIC INSTRUMENTATION TO PERFORM DISSECTION DURING THE INITIAL PORTION OF THE SURGICAL PROCEDURE AND THAT THE DA VINCI S SURGICAL PROCEDURE WAS UTILIZED TO COMPLETE THE SURGICAL PROCEDURE. THE CSR INDICATED THAT SHE OBSERVED THAT AFTER COMPLETION OF THE SURGICAL PROCEDURE, THE SYSTEM WAS UNDOCKED AND MOVED AWAY FROM THE PATIENT AND SHE OBSERVED THAT THE SURGEON WAS PERFORMING AN INSPECTING THE SURGICAL AREA. THE CSR DISCUSSED THE ISSUE WITH THE PROCTOR, AND THE PROCTOR INDICATED TO HER THAT THE SURGEON MAY HAVE HIT THE PATIENT'S BOWEL AND THAT IF A BOWEL INJURY HAD OCCURRED; IT WAS LIKELY INTRODUCED PRIOR TO USE OF THE DA VINCI SURGICAL SYSTEM. THE CSR INDICATED THAT SHE WAS PRESENT DURING THE ENTIRE SURGICAL PROCEDURE AND SHE DID NOT OBSERVE ANY MALFUNCTION OF THE SITE'S DA VINCI S SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES. BASED ON THE LIMITED INFORMATION PROVIDED, IT IS INDETERMINABLE AS TO HOW DAMAGE WAS INTRODUCED TO THE PATIENT'S BOWEL. ISI HAS CONTACTED THE SITE TO OBTAINED ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER COMPLETION OF GENERAL SURGICAL PROCEDURE USING TRADITIONAL LAPAROSCOPIC TECHNIQUES AND THE DA VINCI S SURGICAL SYSTEM, THE SURGEON WAS CONCERNED THAT HE MAY HAVE HIT THE PATIENT'S BOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17733 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P7

    Patients

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