BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3062317 · Received April 16, 2013

    Report

    Report Number
    2955842-2013-01254
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 14, 2012
    Report Date
    March 18, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ISI HAS MADE SEVERAL ATTEMPTS TO CONTACT THE SITE'S RISK MANAGEMENT DEPARTMENT TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA IF ADDITIONAL INFORMATION IS RECEIVED. ISI'S REVIEW OF THE SITE'S SYSTEM LOG FOR THE REPORTED PROCEDURE DATE FOUND THAT THERE WERE NO OCCURRENCES OF ANY SYSTEM ERRORS THAT CAUSED OR CONTRIBUTED TO THE ALLEGED INJURY SUSTAINED BY THE PATIENT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, ISI RECEIVED A LEGAL COMPLAINT ALLEGING THAT A PATIENT WHOM UNDERWENT A DA VINCI SI GYNECOLOGICAL PROCEDURE ON (B)(6) 2012 AT (B)(6) MEDICAL CENTER IN (B)(6), EXPERIENCED PAIN, SUFFERING AND BLEEDING POST THE SURGICAL PROCEDURE. THE LEGAL COMPLAINT ALLEGES THAT UPON THE PATIENT'S FOLLOW UP WITH HER TREATING PHYSICIAN, THE PHYSICIAN INDICATED TO HER THAT THE POST-SURGICAL COMPLICATIONS SHE WAS EXPERIENCING WERE A NORMAL PART OF THE RECOVERY FROM HER SURGERY. THE LEGAL COMPLAINT ALLEGED THAT ON (B)(6) 2012 THE PATIENT MET WITH HER TREATING PHYSICIAN DUE TO EXTENSIVE GYNECOLOGICAL BLEEDING. IT WAS ALLEGED THAT THE TREATING PHYSICIAN DIRECTED THE PATIENT TO THE EMERGENCY ROOM AT (B)(6) MEDICAL CENTER. IT WAS DISCOVERED THAT THE PATIENT REQUIRED AN EMERGENCY SURGICAL PROCEDURE TO CORRECT A SURGICAL DEFECT THAT WAS CAUSED BY THE SITE'S DA VINCI SI SURGICAL SYSTEM. THIS WAS NOT DISCOVERED DURING THE PATIENT'S SURGICAL PROCEDURE PERFORMED ON (B)(6) 2012. REPORTEDLY, FOLLOWING THE EMERGENCY SURGICAL PROCEDURE, THE PATIENT WAS HOSPITALIZED AND CONFINED TO HER BED FOR MANY DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162400 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A60.P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DA VINCI SI SYSTEM INSTRUMENTS, ACCESSORIES & ESU