BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3971105 · Received July 31, 2014

    Report

    Report Number
    2955842-2014-04640
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 2, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE INTRA-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT IS INDETERMINABLE. THE DA VINCI SURGICAL SYSTEM DID NOT MALFUNCTION IN A WAY THAT CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT; BUT LIKELY OCCURRED DUE TO THE SURGEON'S INABILITY TO GAIN ADEQUATE TRACTION WHILE ATTEMPTING TO OPEN THE PATIENT'S TISSUE PLANES. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI CHOLECYSTECTOMY PROCEDURE, THE PATIENT'S COMMON BILE DUCT WAS NICKED. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE THAT CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI CHOLECYSTECTOMY PROCEDURE, THE PATIENT'S COMMON BILE DUCT WAS INJURED. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THIS COMPLAINT. ACCORDING TO THE CSR, SHE WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. HOWEVER, SHE WAS TOLD BY THE SURGEON AND ROBOTICS COORDINATOR THAT DURING THE SURGICAL PROCEDURE, THE PATIENT EXPERIENCED COMPLICATIONS DUE TO A COMMON BILE DUCT INJURY AND THE SURGEON MADE THE DECISION TO REPAIR AND COMPLETE THE PROCEDURE USING OPEN SURGICAL TECHNIQUES. THE CSR WAS UNABLE TO PROVIDE ANY OTHER DETAILS REGARDING THE REPORTED EVENT. ON (B)(4) 2014, ISI CONTACTED THE SITE'S ROBOTICS COORDINATOR TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE ROBOTICS COORDINATOR, IT WAS INITIALLY BELIEVED THAT THE PATIENT'S BILE DUCT WAS SEVERED; HOWEVER, A CHOLANGIOGRAPHY WAS PERFORMED AND IT SHOWED THAT THE PATIENT'S COMMON BILE DUCT WAS NICKED. ON (B)(4) 2014, ISI CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. ACCORDING TO THE SURGEON, THE DEFECT TO THE PATIENT'S COMMON BILE DUCT WAS OBSERVED IMMEDIATELY. THE NEXT DAY THE PATIENT WAS TRANSPORTED TO ANOTHER AREA HOSPITAL AND UNDERWENT AN OPEN SURGICAL PROCEDURE FOR REPAIR OF THE DEFECT. THE PATIENT HAS BEEN DISCHARGED HOME IS RECOVERING WELL. ACCORDING TO THE SURGEON THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES DURING THE SURGICAL PROCEDURE THAT CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY. THE SURGEON INDICATED THAT HE BELIEVES THE DEFECT TO THE PATIENT'S COMMON BILE DUCT OCCURRED DUE TO INADEQUATE TRACTION WHILE OPENING THE PATIENT'S TISSUE PLANES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447914 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