BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3166303 · Received June 12, 2013

    Report

    Report Number
    2955842-2013-02131
    Event Type
    Injury
    Date Received
    June 12, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 13, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, AN INTUITIVE SURGICAL INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION OF THE DA VINCI SI SURGICAL SYSTEM AT THE SITE. THE FSE PROVIDED THE FOLLOWING INFORMATION: A GRAVITY COMPENSATION TEST WAS PERFORMED ON BOTH MASTER TOOL MANIPULATORS (MTM) OF SURGEON SIDE CONSOLE (SSC) 1. BOTH MTM'S PASSED. A GRAVITY CALIBRATION WAS ALSO PERFORMED ON BOTH MTM'S OF SSC 2 WHICH WAS USED BY A RESIDENT. THE RIGHT MTM WAS FOUND TO BE WITHIN SPECIFICATION. ACCORDING TO THE FSE, THE LEFT MTM NEEDED RECALIBRATION. THE FSE PERFORMED A GRAVITY CALIBRATION OF THE LEFT MTM. THE SYSTEM PASSED A BRAKE HOLDING TEST ON ALL PSM'S. A SINE CYCLE WAS PERFORMED AND ALL PSM'S WERE TEST DRIVEN ON BOTH CONSOLES. IN ADDITION, GRAVITY COMPENSATION WAS TESTED ON BOTH CONSOLES. THE FSE INDICATED THAT NO UNUSUAL DRIFTING OF THE INSTRUMENTS WAS OBSERVED BEFORE AND AFTER THE GRAVITY CALIBRATION TESTS WERE PERFORMED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE REGARDING THE REPORTED SURGICAL PROCEDURE. ACCORDING TO THE SYSTEM LOG, APPROXIMATELY 2 HOURS INTO THE SURGICAL PROCEDURE, AN ERROR 100 WAS RECORDED. THE ERROR 100 SIGNIFIED THAT AT THAT MOMENT, THE SETUP JOINT (SUJ1, JOINT 4) OF THE RIGHT PSM WAS BUMPED. IT IS UNKNOWN AT THIS TIME IF THE ERROR 100 OCCURRED AT THE TIME THE RIGHT PSM INADVERTENTLY MOVED ACCORDING TO THE SURGEON. ON (B)(4) 2013, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) ASSIGNED TO THE SITE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE CSR DESCRIBED THE INJURY TO THE PATIENT'S BOWEL/COLON AS BEING MORE OF A SEROSAL TEAR. HE DENIED THAT THE PATIENT'S BOWEL/COLON WAS PERFORATED. TO HIS KNOWLEDGE, THE PATIENT DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS. THE CSR ALSO INDICATED THAT THE DA VINCI SI SURGICAL SYSTEM WAS USED IN SUBSEQUENT SURGICAL PROCEDURE WITHOUT ANY REPORTED ISSUES SINCE THE EVENT OCCURRED. THE CSR DID NOT KNOW IF THE SURGEON'S HEAD WAS WITHIN THE HIGH RESOLUTION STEREO VIEWER (HRSV) OR IF SHE WAS GRASPING THE MTM'S WHEN THE INJURY OCCURRED. ON (B)(4) 2013, ISI OBTAINED ADDITIONAL INFORMATION FROM THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE INVOLVED WITH THIS COMPLAINT. THE SURGEON PROVIDED THE FOLLOWING INFORMATION: HER HEAD WAS IN THE HIGH RESOLUTION STEREO VIEWER (HRSV) AND HER FINGERS WERE THROUGH THE VELCRO GRIPS OF THE MTM'S WHEN THE RIGHT PSM OF THE PATIENT SIDE CART (PSC) MOVED INADVERTENTLY. HOWEVER, THE SURGEON DENIED THAT SHE MOVED ANY OF THE TOOLS WHEN THE RIGHT PSM INADVERTENTLY MOVED. THE SURGEON INDICATED THAT THE PATIENT'S BOWEL/COLON WAS PERFORATED BY A PK DISSECTING FORCEPS INSTRUMENT WHEN THE RIGHT PSM MOVED. SHE WAS UNABLE TO PROVIDE THE SERIAL AND LOT OF THE INSTRUMENT. AFTER THE INJURY OCCURRED, THE SURGEON USED THE DA VINCI SI SURGICAL SYSTEM TO REPAIR THE PERFORATED BOWEL/COLON. THE SURGEON INDICATED THAT SHE CONTINUED TO USE THE RIGHT PSM INSTALLED ON THE PSC AND THE PK DISSECTING FORCEPS INSTRUMENT DURING THE REMAINDER OF THE SURGICAL PROCEDURE AND NO OTHER ISSUES WERE OBSERVED. THE SURGEON INDICATED THAT THE PATIENT DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS. ACCORDING TO THE SURGEON, THE PATIENT WAS CURRENTLY STABLE. THE SURGEON INDICATED THAT THE DA VINCI SI SURGICAL SYSTEM INVOLVED WITH THIS COMPLAINT HAS BEEN USED IN SUBSEQUENT SURGICAL PROCEDURES SINCE THE REPORTED EVENT OCCURRED. IN ADDITION, TO HER KNOWLEDGE, THE PSM INSTALLED ON THE PSC INVOLVED WITH THIS COMPLAINT HAS BEEN WORKING PROPERLY. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON CLAIMED THAT THE RIGHT ARM OF THE PSC MOVED WITHOUT HER INPUT AND THE PATIENT'S BOWEL/COLON WAS PIERCED. HOWEVER, AT THIS TIME IT IS UNKNOWN IF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI SACROCOLPOPEXY PROCEDURE, THE SURGEON INDICATED THAT THE RIGHT PATIENT SIDE MANIPULATOR (PSM) ON THE PATIENT SIDE CART (PSC) INADVERTENTLY MOVED AND THE PATIENT'S BOWEL/COLON WAS PIERCED. AT THE TIME THAT THE INJURY OCCURRED, THE PSC WAS DOCKED TO THE PATIENT AND INSTRUMENTS WERE INSERTED. THE SURGEON INDICATED THAT WHEN SHE REACHED FOR THE MASTER TOOL MANIPULATORS (MTM), THE RIGHT PSM MOVED WITHOUT HER INPUT. THE PATIENT'S BOWEL WAS REPAIRED VIA SUTURING AND THE SURGICAL PROCEDURE WAS COMPLETED WITH THE DA VINCI SI SURGICAL SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265440 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 DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES