BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3920283 · Received July 8, 2014

    Report

    Report Number
    2955842-2014-04159
    Event Type
    Other
    Date Received
    July 8, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ECM WAS RETURNED TO ISI AND EVALUATED. A VISUAL EXAMINATION OF THE ECM REVEALED FRAYED AND DERAILED AXIS 4 CABLES. 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 ABORT THE DA VINCI SURGICAL PROCEDURE AFTER A BROKEN WIRE WAS OBSERVED ON THE ECM WHERE THE CAMERA MOUNTS. AT THE TIME THE EVENT OCCURRED, THE DA VINCI PATIENT SIDE CART (PSC) HAD NOT YET BEEN DOCKED TO THE PATIENT. HOWEVER, THE PATIENT WAS ALREADY UNDER ANESTHESIA AND INCISION PORTS HAD BEEN PLACED.

    Additional Manufacturer Narrative · 1

    ON 07/14/2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE SITE'S ROBOTICS COORDINATOR INDICATED THAT THE CASE WAS ABORTED POST-ANESTHESIA AND PORT PLACEMENT AFTER A WIRE WAS NOTICED TO BE BROKEN ON THE ENDOSCOPIC CAMERA MANIPULATOR (ECM). THE PATIENT WAS RESCHEDULED FOR THE DA VINCI SURGICAL PROCEDURE THE FOLLOWING DAY/MORNING. THE RESCHEDULED PROCEDURE WAS SUCCESSFULLY COMPLETED AND NO POST-OPERATIVE COMPLICATIONS WERE REPORTED. ACCORDING TO THE ROBOTICS COORDINATOR, THE SITE HAS 2 DA VINCI SURGICAL SYSTEMS AND SHE DID NOT KNOW WHICH ONE WAS USED DURING THE RESCHEDULED PROCEDURE. THE ECM WAS REPLACED BY AN ISI FIELD SERVICE ENGINEER (FSE) AND THERE WERE NO REPORTED RECURRENCES OF THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI HYSTERECTOMY PROCEDURE, THE SURGICAL STAFF NOTICED A WIRE COMING OUT OF WHERE THE CAMERA MOUNTS ON THE ENDOSCOPIC CAMERA MANIPULATOR (ECM). DUE TO THE REPORTED ISSUE, THE SURGEON MADE THE DECISION TO ABORT THE PLANNED DA VINCI SURGICAL PROCEDURE. AT THE TIME THE EVENT OCCURRED, THE PATIENT WAS UNDER ANESTHESIA AND THE INCISION PORTS HAD ALREADY BEEN PLACED. ON (B)(4) 2014, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE FOUND A FRAYED CABLE ON AXIS 4 OF THE ECM. THE FSE REPAIRED THE SYSTEM BY REPLACING THE ECM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398158 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other