BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEBAKEY FORCEPS INSTRUMENT

    MDR report key: 2816230 · Received November 1, 2012

    Report

    Report Number
    2955842-2012-00770
    Event Type
    Injury
    Date Received
    November 1, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 3, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SIDE MANIPULATOR (PSM) WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING EVALUATION DETECTED SOME FRICTION DURING FUNCTIONAL TESTING AFTER INSTALLING AN IN-HOUSE ISI ENDOWRIST INSTRUMENT ONTO THE PSM. ENGINEERING WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED FAILURE MODE OF THE PSM JUMPING, AFTER ONE HOUR OF FUNCTIONAL TESTING. A VISUAL INSPECTION OF THE PSM FOUND THAT CABLE 1 WITHIN AXIS 3 WAS CROSSED ROUTED. THIS NON-STANDARD ROUTING OF CABLE 1 CAUSED THE CABLE TO RUB AGAINST CABLE 2 WITHIN AXIS 3, WHICH RESULTED IN NON-INTUITIVE MOTION OF THE INSTRUMENT INSTALLED ON THE PSM DURING TESTING. A FRICTION TEST ALSO PERFORMED SHOWED HIGH FRICTION ON AXIS 3; HOWEVER, FRICTION AND JOINT TORQUE PLOTS FOR THE PSM SHOWED NO DISCONTINUITIES. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART AND PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. ISI INVESTIGATION HAS CONCLUDED THAT THE JUMPING MOTION OF THE PSM EXPERIENCED BY THE CUSTOMER WAS NOT LIKELY CAUSED BY THE CABLE ROUTING, AS FUNCTIONAL TESTING OF THE PSM DID NOT CAUSE UNINTENDED MOTION. THE PSM'S MECHANICAL CABLES WERE REPLACED.

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012, THE ISI FIELD SERVICE ENGINEER (FSE) CONTACTED (B)(6), THE INITIAL REPORTER, AND SHE INDICATED THAT DURING THE SURGICAL PROCEDURE, THE SITE EXPERIENCED DIFFICULTY INSTALLING AND REMOVING THE ENDOWRIST INSTRUMENTS. (B)(6) INDICATED THAT NO SYSTEM ERROR OR ALARMS OCCURRED. (B)(6) INDICATED THAT THE TOUCHSCREEN MONITOR SEEMED TO FLICKER SIMULTANEOUSLY WHEN THE PATIENT SIDE MANIPULATOR (PSM) ARM JUMPED. (B)(6) INDICATED THAT THE STERILE DRAPED DID NOT APPEAR TO HAVE CAUSED ANY BINDING DURING THE SURGICAL PROCEDURE, AND THERE WAS NO PHYSICAL DAMAGE TO THE PSM OBSERVED. ON (B)(4) 2012, THE FSE ARRIVED AT THE SITE TO PERFORM AN EVALUATION OF THE SITE'S DA VINCI SYSTEM AND THE FSE LEARNED THAT (B)(6) WAS NOT IN THE OPERATING ROOM WHEN THE REPORTED EVENT OCCURRED AND THAT ANOTHER NURSE PRESENT DURING THE SURGICAL PROCEDURE OBSERVED A BLUR OF THE INSTRUMENT TIP PASSING IN FRONT OF THE ENDOSCOPE ON THE TOUCHSCREEN MONITOR. (B)(6) REFERRED THE FSE TO THE SURGICAL TECHNICIAN, (B)(6) (SURNAME UNKNOWN) WHO WAS PERFORMING AN INSTRUMENT EXCHANGE DURING THE SURGICAL PROCEDURE WHEN THE EVENT OCCURRED. (B)(6) INDICATED TO THE FSE THAT THE ISSUE OCCURRED AFTER INSTALLATION OF THE DEBAKEY FORCEPS INSTRUMENT ON PSM 2 AND WHILE INSTALLING A CLIP APPLIER INSTRUMENT ON PSM 1. (B)(6) INDICATED THAT HE EXPERIENCED DIFFICULTY INSERTING AND REMOVING INSTRUMENTS THROUGH THE CANNULA INSTALLED ON PSM 2 AND THAT INSPECTION OF THE DRAPE INSTALLED ON THE PSM, THE DRAPE DID NOT APPEAR TO BE IN THE WAY. (B)(6) INDICATED THAT THE SURGEON LEFT THE SURGEON SIDE CONSOLE (SSC) MULTIPLE TIMES TO ENSURE THAT THE PSMS WERE NOT COLLIDING OR RUBBING TOGETHER. (B)(6) ALSO INDICATED TO THE FSE THAT AFTER CONVERSION OF THE PLANNED SURGICAL PROCEDURE TO OPEN TECHNIQUES, INSPECTION OF THE CANNULAE USED DURING THE SURGICAL PROCEDURE FOUND NO DAMAGE. THE FSE SPOKE TO DR (B)(6), THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE AND DR (B)(6) INDICATED THAT THE PLANNED SURGICAL PROCEDURE WAS PROGRESSING SMOOTHLY. THE SURGEON INDICATED TO THE FSE THAT HE WAS POSITIONING THE MAMMARY ARTERY FOR CLIPPING WHEN HE LOST CONTROL OF THE DEBAKEY INSTRUMENT INSTALLED ON PSM 2. THE FSE INDICATED THAT DR (B)(6) DESCRIBED THE INSTRUMENT AS LUNGING FORWARD AND TURNED; BUT NOT A FULL 360 DEGREES. THE SURGEON INDICATED THAT THE INSTRUMENTS WERE NOT MANIPULATING CORRECTLY AT TIMES, AND HE WOULD GO OVER TO THE PATIENT SIDE CART TO INSPECT THE PSMS TO ENSURE THAT THERE WERE NO OBSTRUCTIONS, AS HE FELT THAT THERE WAS A LOT OF TENSION ON PSM 2. THE INVESTIGATION CONDUCTED BY THE FSE WAS UNABLE TO REPLICATE THE ISSUE EXPERIENCED BY THE SITE. THE FSE PERFORMED FUNCTIONAL TESTING USING THE ENDOWRIST INSTRUMENTS AND CANNULAE THAT WERE USED DURING THE SURGICAL PROCEDURE AND THE INSTRUMENTS FUNCTIONED PROPERLY WITH NO ISSUES NOTED AND THE SYSTEM FUNCTIONED WITHIN SPECIFICATION. THE FSE ALSO PERFORMED AN INSPECTION OF THE INSTRUMENTS AND CANNULAE USED DURING THE SURGICAL PROCEDURE AND THERE WAS NO DAMAGE FOUND. REVIEW OF THE SYSTEM LOG BY THE FOR THE PROCEDURE DATE FOUND THAT SYSTEM ERROR CODE 31009 OCCURRED THUS INDICATING THAT THE CONNECTION OF THE INSTRUMENTS USED DURING THE SURGICAL PROCEDURE, TO THE SYSTEM WAS INTERMITTENT. SYSTEM ERROR CODE 31009 IS AN INFORMATIONAL ERROR CODE AND OCCURS WHEN AN INSTRUMENT IS INITIALLY DETECTED, AND THEN ONE OR MORE SENSORS INPUTS INDICATE THE PRESENCE OF THE INSTRUMENT WAS MISSING FOR 3 SECONDS. THE STERILE ADAPTERS WERE NOT AVAILABLE FOR EVALUATION, AS THE SITE INDICATED THAT THEY WERE DISCARDED. WHILE ATTEMPTING TO REPLICATE THE INCIDENT, THE ISI IN-HOUSE ENGINEERING WAS ABLE TO OBSERVE THE FOLLOWING SCENARIO: WHEN HOLDING THE MASTER TOOL MANIPULATORS (MTM) ON THE SURGEON SIDE CART IN PLACE, A TRANSLATIONAL FORCE WAS APPLIED TO THE PATIENT SIDE MANIPULATORS (PSM) ARMS ON THE PATIENT SIDE CART (PSC). DEPENDING ON THE DIRECTION OF THE EXERTED FORCE AND THE ORIENTATION OF THE MTM, THE ROLL AXIS OF THE MTM MOVED BY AS MUCH AS 60 DEGREES. ENGINEERING INVESTIGATION HAS SUGGESTED THAT THE INJURY SUSTAINED BY THE PATIENT, MAY HAVE BEEN DUE TO INADVERTENT BUMPING OF THE PSM OR THE PSC DURING THE SURGICAL PROCEDURE WHILE EXCHANGING INSTRUMENTS. FORCES FROM SUCH A BUMP COULD CAUSE MOVEMENT OF THE INSTRUMENT, WHICH WOULD RESULT IN THE MOVEMENT OF THE MTM THROUGH FORCE REFLECTION, AND THEN THE ROLL AXIS COULD MOVE, THUS LEADING TO INSTRUMENT TIP ROLL MOTION. ISI HAS CONTACTED DR (B)(6) TO VERIFY THE CURRENT STATUS OF THE PATIENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. AS OF (B)(6) 2012, THE HOSPITAL HAS CONTINUED TO USE THE SYSTEM WITH NO REPORTED RECURRENCES OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S CARDIAC PROCEDURE, THE PATIENT SIDE MANIPULATOR (PSM) ARM 2 JUMPED CAUSING THE DEBAKEY FORCEPS INSTRUMENT INSTALLED ON THAT PSM TO LACERATE THE PATIENT'S MAMMARY ARTERY. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED USING OPEN SURGICAL TECHNIQUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEBAKEY FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420036

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other| R DA VINCI S SURG SYSTEM AND ACCESSORIES