BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3667648 · Received March 7, 2014

    Report

    Report Number
    2955842-2014-01375
    Event Type
    Other
    Date Received
    March 7, 2014
    Date of Event
    October 11, 2011
    Report Date
    February 13, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE CUSTOMER REPORTED FAILURE MODE. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS ATTEMPTED TO CONTACT THE SITE 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 SURGEON MADE THE DECISION TO CONVERT THE DA VINCI HYSTERECTOMY PROCEDURE TO OPEN SURGICAL TECHNIQUES AFTER ENCOUNTERING UNSPECIFIED ISSUES WITH THE LEFT ARM OF THE DA VINCI SURGICAL SYSTEM.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY FOR ABNORMAL UTERINE BLEEDING ON (B)(6) 2011. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. THE SURGEON INDICATED THAT WITH A PK, THE LEFT SIDE WAS TAKEN DOWN. THE ROUND LIGAMENT WAS TAKEN DOWN, AS WELL AS THE LEFT UTERO-OVARIAN LIGAMENT, LEFT TUBE, BROAD LIGAMENT, AND THE BLADDER FLAP WAS CREATED. THE SURGEON THEN NOTED, HOWEVER, BEFORE SWITCHING OVER TO THE CONTRALATERAL SIDE, THE LEFT ARM WAS HAVING DIFFICULTIES AND AFTER SEVERAL ATTEMPTS TO GET THE MACHINE REBOOTED, IT WAS DETERMINED TO JUST PROCEED TO AN OPEN PROCEDURE. ALL INSTRUMENT WERE REMOVED. THE DAVINCI WAS UNDOCKED AND THEN I PROCEED TO PERFORM A PFANNENSTIEL INCISION. AT THE CONCLUSION OF THE SURGICAL PROCEDURE, THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138821 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P7

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other