BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 3380065 · Received October 1, 2013

    Report

    Report Number
    2955842-2013-03880
    Event Type
    Injury
    Date Received
    October 1, 2013
    Date of Event
    January 8, 2011
    Report Date
    September 4, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE OPERATIVE COMPLICATION(S) EXPERIENCED BY THE PATIENT. THE JOURNAL ARTICLE DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED IN RELATION TO THE REPORTED EVENT. ISI HAS MADE SEVERAL ATTEMPTS TO CONTACT A PHYSICIAN WHO CO-AUTHORED THE JOURNAL ARTICLE 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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE JOURNAL ARTICLE INDICATED THAT AN UNSPECIFIED PATIENT INJURY OCCURRED IN RELATION TO A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, IT IS UNKNOWN WHAT TYPE OF PATIENT INJURY OCCURRED OR HOW THE PATIENT WAS INJURED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A JOURNAL ARTICLE BY COOPER ET AL TITLED, UNDERREPORTING OF ROBOTIC SURGERY COMPLICATIONS. IN THIS ARTICLE, THE AUTHORS REPORTED COMPLICATIONS REPORTED IN MAUDE DATABASE OR LEXISNEXIS, AND PACER (PUBLIC ACCESS TO COURT ELECTRONIC RECORDS) FROM (B)(6) 2000 TO (B)(6) 2012. ACCORDING TO THE ARTICLE, IT WAS REPORTED THAT AN UNSPECIFIED PATIENT INJURY OCCURRED IN RELATION TO DEVICE ASSEMBLY OF AN UNSPECIFIED DA VINCI SURGICAL PROCEDURE PERFORMED ON (B)(6) 2011. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENT. THE HOSPITAL NAME, DA VINCI SYSTEM SERIAL, AND TYPE OF PROCEDURE INVOLVED WITH THIS COMPLAINT WERE NOT INCLUDED IN THE ARTICLE. ARTICLE INFORMATION: TITLE: UNDERREPORTING OF ROBOTIC SURGERY COMPLICATIONS AUTHORS: MICHOL A. COOPER, ANDREW IBRAHIM, HEATHER LYU, MARTIN A. MAKARY PUBLISHED DATE: 08/27/2013 LINK: HTTP://ONLINELIBRARY.WILEY.COM/DOI/10.1111/JHQ.12036/ABSTRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494644 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC.

    Patients

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