BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3157008 · Received June 8, 2013

    Report

    Report Number
    2955842-2013-02049
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER OF THIS INCIDENT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER INDICATED THAT DURING THE SURGICAL PROCEDURE TWO MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENTS WERE USED ON PATIENT SIDE MANIPULATOR (PSM) 1. DURING THE SURGICAL PROCEDURE, THE FIRST MCS INSTRUMENT INSTALLED ON PSM 1 ALLEGEDLY BECAME STUCK AND WAS DIFFICULT TO REMOVE. THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY WERE REPORTEDLY INSPECTED PRIOR TO THE PROCEDURE BY THE SURGICAL STAFF AND NO DAMAGE WAS OBSERVED. THE SITE REPORTEDLY DECIDED TO USE A REPLACEMENT MCS INSTRUMENT DUE TO THE REPORTED DIFFICULTY THEY HAD WITH REMOVING THE FIRST MCS INSTRUMENT FROM THE CANNULA. THE FIRST MCS INSTRUMENT WAS INSPECTED UPON REMOVAL FROM THE CANNULA AND NO DAMAGE WAS FOUND BY THE SURGICAL STAFF. WHILE USING THE SECOND MCS INSTRUMENT ON PSM 1, THE SURGEON AND SURGICAL STAFF ALLEGED THAT PSM 1 JERKED FORWARD, CAUSING THE MCS INSTRUMENT TO PUNCTURE ONE OF THE PATIENT'S ARTERIES. AT THE TIME PSM 1 ALLEGEDLY JERKED FORWARD, THE SURGEON WAS REPORTEDLY PERFORMING A DISSECTION OF THE PATIENT'S MIDDLE SACRAL LIGAMENT AND WAS NOT CUTTING OR CAUTERIZING TISSUE. ACCORDING TO THE INITIAL REPORTER, THE SURGEON WAS REPORTEDLY USING THE MCS INSTRUMENT TO PUSH THE PATIENT'S ANATOMY BACK. THE PATIENT'S ARTERY WAS REPORTEDLY REPAIRED USING CLIPS INSTALLED ON AN ENDOWRIST CLIP APPLIER INSTRUMENT. THE SECOND MCS INSTRUMENT WAS INSPECTED BY THE SURGICAL STAFF AFTER THE INCIDENT OCCURRED AND SINCE NO DAMAGE WAS FOUND, THE SURGEON MADE THE DECISION TO COMPLETE THE SURGICAL PROCEDURE WITH THE SAME INSTRUMENT INSTALLED ON PSM 3. THE INITIAL REPORTER INDICATED THAT THE SURGEON DID NOT MOVE HIS HEAD FROM THE HIGH RESOLUTION STEREO VIEWER (HRSV) OR REMOVE HIS HANDS FROM THE MASTER TOOL MANIPULATORS (MTM) WHEN THE REPORTED INJURY OCCURRED. THE INITIAL REPORTER DENIED THAT ANY SYSTEM ALARMS OR ERROR MESSAGES OCCURRED WHEN PSM 1 ALLEGEDLY JERKED. THE SURGICAL PROCEDURE WAS REPORTEDLY NOT RECORDED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY OTHER MEDICAL TREATMENTS OR SURGICAL INTERVENTION BECAUSE OF THE ALLEGED ISSUE. THE PATIENT REPORTEDLY TOLERATED THE SURGICAL PROCEDURE WELL AND WAS RECOVERING. THE PATIENT WAS IN STABLE CONDITION. ON (B)(4) 2013, A FIELD SERVICE ENGINEER (FSE) PERFORMED A SYSTEM VERIFICATION AT THE SITE AND NO ISSUES WERE FOUND WITH PSM 1. THE FSE ALSO NOTED THAT THREE SUBSEQUENT SURGICAL PROCEDURES HAD BEEN COMPLETED WITH THE SYSTEM SINCE THE REPORTED EVENT OCCURRED. ON (B)(4) 2013, ISI CONTACTED THE FSE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE FSE INDICATED THAT DURING HIS FIELD EVALUATION, HE WAS DENIED ACCESS TO THE AFFECTED MCS INSTRUMENTS AND STERILE ADAPTER BY THE SITE SINCE THE PRODUCTS WERE IN QUARANTINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI SACROCOLPOPEXY PROCEDURE, THE PATIENT SIDE MANIPULATOR (PSM) ARM 1 ALLEGEDLY JUMPED AND ONE OF THE PATIENT'S ARTERIES WAS NICKED BY THE INSTRUMENT INSTALLED ON PSM 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259071 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 SURG SYS INST., ACCESSORIES, & ESU