BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SYSTEM

    MDR report key: 3891371 · Received June 24, 2014

    Report

    Report Number
    2955842-2014-03857
    Event Type
    Other
    Date Received
    June 24, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K021036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE CABLE INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS WAS UNABLE TO REPLICATE THE REPORTED ERROR CODE 153 ISSUE. FAILURE ANALYSIS CONNECTED THE SET UP JOINT (SUJ) HARNESS TO THE TEST SYSTEM AND THE TEST SWITCH ON BOTH THE SETUP JOINT AND THE PATIENT SIDE MANIPULATOR (PSM). BOTH SWITCHES PERFORMED NORMALLY WHEN PRESSED AND RELEASED SEVERAL TIMES IN NORMAL MODE. THE SUJ HARNESS PASSED VISUAL INSPECTION. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. AN ERROR 153 IS TRIGGERED BY A SIGNAL FROM THE PROTECTION CIRCUIT WITHIN A HIGH-SIDE DRIVER SWITCH. THIS SIGNAL INDICATES THAT THE PROTECTION CIRCUIT HAS LIMITED OUTPUT POWER TO PROTECT THE CIRCUIT. IT IS USUALLY AN INDICATION OF A SHORT CIRCUIT WITHIN THE SUBSYSTEM THAT IS DRIVEN BY THE HIGH-SIDE CIRCUITRY. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON DECIDED TO ABORT THE DA VINCI PROCEDURE POST- ANESTHESIA DUE TO AN ERROR 153.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI PROSTATECTOMY PROCEDURE, A NON-RECOVERABLE ERROR CODE 153 OCCURRED WHEN THE SURGEON WAS CLUTCHING THE PATIENT SIDE MANIPULATOR 2 (PSM2). THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. THE HOMING POSITION OF THE SYSTEM WAS CORRECT; HOWEVER, WHEN THE NURSE TRIED TO CLUTCH PSM2, THE ERROR CODE WAS TRIGGERED. THE INSTRUMENT CLUTCH DID NOT TRIGGER ANY ERROR MESSAGES. DUE TO THE ALLEGED ERROR 153, THE SURGEON MADE THE DECISION TO ABORT THE PROCEDURE POST- ANESTHESIA. INTUITIVE SURGICAL, INC. (ISI) CONTACTED A NURSE FROM THE SITE AND OBTAINED THE FOLLOWING INFORMATION: THE ALLEGED ISSUE WITH THE ERROR MESSAGE OCCURRED DURING SETUP OF THE SYSTEM. NO PORTS WERE PLACED ON THE PATIENT. IT IS UNKNOWN HOW LONG THE PATIENT WAS UNDER ANESTHESIA. THE SURGICAL PROCEDURE WAS RESCHEDULED; HOWEVER THE EXACT DATE WAS NOT PROVIDED. A FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND REPLACED THE SUJ CABLE AND THE ISSUE WAS RESOLVED. THE SYSTEM HAS BEEN USED AFTER THE FSE VISITED THE SITE. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367755 DA VINCI SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS1200 A4.3P9

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR