BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 4250929 · Received November 14, 2014

    Report

    Report Number
    2955842-2014-05666
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 17, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE INTRA-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT. THERE IS NO INDICATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2010. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S INTRA-OPERATIVE COMPLICATION. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING THE DA VINCI SURGICAL PROCEDURE, AN UNIDENTIFIED ARTERY WAS INJURED AND REQUIRED REPAIR VIA OPEN SURGERY. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S INTRA-OPERATIVE COMPLICATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI ABDOMINOPERINEAL RESECTION PROCEDURE, THE SURGEON NICKED AN UNSPECIFIED ARTERY. THE SURGEON WAS ABLE TO USE AN UNIDENTIFIED INSTRUMENT TO CLAMP THE ARTERY. THE SURGEON THEN MADE THE DECISION TO CONVERT THE DA VINCI SURGICAL PROCEDURE TO OPEN SURGICAL TECHNIQUES IN ORDER TO REPAIR THE INJURED VESSEL. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ON 11/12/2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO INITIALLY REPORTED THIS COMPLAINT. THE CSR WAS PRESENT DURING THE SURGICAL PROCEDURE. HE REITERATED THAT NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. THE CSR STATED THAT BLEEDING WAS OBSERVED FROM A SUPERIOR VESSEL BUT THE CAUSE OF THE VESSEL INJURY WAS NOT DETERMINED OR IDENTIFIED. THE CSR COULD NOT VERIFY THAT THE ARTERY WAS ACTUALLY NICKED. THE CASE WAS CONVERTED TO OPEN SURGERY IN ORDER TO REPAIR THE VESSEL INJURY. THE ABDOMINOPERINEAL RESECTION PROCEDURE WAS COMPLETED SUCCESSFULLY VIA OPEN SURGERY AND NO POST-OPERATIVE COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736741 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention