BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 4841021 · Received June 12, 2015

    Report

    Report Number
    2955842-2015-00886
    Event Type
    Injury
    Date Received
    June 12, 2015
    Date of Event
    May 13, 2015
    Report Date
    May 14, 2015
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE OF THE INTRA-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. 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. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2015 REVEALED THAT NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE, THE PATIENT SUSTAINED A VESSEL INJURY, LOST APPROXIMATELY 3 LITERS OF BLOOD, AND RECEIVED A BLOOD TRANSFUSION. HOWEVER, AT THIS TIME, THE CAUSE OF THE VESSEL INJURY IS UNCLEAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PARTIAL NEPHRECTOMY PROCEDURE, THE ELECTROSURGICAL UNIT (ESU) TURNED ON WHILE THE SURGEON WAS DISSECTING WITH A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. AS A RESULT, THE MCS INSTRUMENT CAUTERIZED AND AN ARTERY RUPTURED. THE SURGEON CLAIMED THAT HIS FEET WERE NOT PRESSING ANY PEDALS ON THE SYSTEM. THE CASE WAS REPORTEDLY CONVERTED TO OPEN SURGERY AND THE PATIENT REQUIRED SEVERAL UNITS OF BLOOD. ON (B)(6) 2015 A CIRCULATOR, WHO WAS PRESENT DURING THE DA VINCI SURGICAL PROCEDURE, INDICATED THAT THE SURGEON WAS COLD DISSECTING WITH THE MCS INSTRUMENT WHEN ENERGY FIRED WITHOUT ACTIVATION BY THE SURGEON. THE CIRCULATOR STATED THAT AN ILIAC ARTERY RUPTURED AND BLED AS A RESULT OF THE ISSUE. THE CASE WAS CONVERTED TO OPEN SURGERY AND A VASCULAR SPECIALIST WAS CONSULTED. THE ESTIMATED BLOOD LOSS OF THE SURGICAL PROCEDURE WAS 3 LITERS AND THE PATIENT RECEIVED BLOOD PRODUCTS. ON (B)(6) 2015, AN ISI TECHNICAL FIELD SPECIALIST (TFS) CONTACTED THE SITE'S ROBOTICS COORDINATOR. THE TFS INDICATED THAT THE SITE HAD REPLACED THE ESU AS WELL AS A CABLE CONNECTED TO THE ESU. THE ROBOTICS COORDINATOR INFORMED THE TFS THAT THE DA VINCI SURGICAL SYSTEM HAD BEEN IN USE WITH NO RECURRENCES OF THE REPORTED CUSTOMER ISSUE. ACCORDING TO THE TFS, THE ROBOTICS COORDINATOR ADMITTED THAT THEY HAD BEEN USING A CONMED CABLE WITH THE ESU. THE TFS INFORMED THE ROBOTICS COORDINATOR THAT THE SITE SHOULD NOT BE USING NON-VALIDATED CABLES FOR USE WITH THE DA VINCI SURGICAL SYSTEM. ON 06/08/2015, ISI CONTACTED THE ISI CLINICAL SERVICE REPRESENTATIVE (CSR) WHO WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. ACCORDING TO THE CSR, THE SURGEON CLAIMED THAT HE PURPOSEFULLY KEPT HIS FEET AWAY FROM THE PEDALS BEFORE THE EVENT OCCURRED AND TO AVOID ACCIDENTAL ACTIVATION OF ENERGY. WHILE DISSECTING WITH THE MCS INSTRUMENT, THE SURGEON CLAIMED THAT THE ESU ACTIVATED ON ITS OWN WHICH RESULTED IN THE ILIAC ARTERY BEING CUT. DURING ATTEMPTED SUTURING OF THE VESSEL INJURY, THE VESSEL REPORTEDLY RUPTURED. THE CASE WAS THEN CONVERTED TO OPEN SURGERY TO REPAIR THE VESSEL. NO OTHER CLINICAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385231 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