BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CAUTERY INSTRUMENT

    MDR report key: 3250546 · Received July 26, 2013

    Report

    Report Number
    2955842-2013-02772
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    May 24, 2013
    Report Date
    July 1, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. AN INTUITIVE SURGICAL INC. (ISI) CLINICAL SALES REPRESENTATIVE WAS ABLE TO OBTAIN ADDITIONAL INFORMATION FROM A SURGEON AT THE SITE REGARDING THE REPORTED EVENT. ACCORDING TO THE SURGEON, THE FRAGMENT WAS RETRIEVED LAPAROSCOPICALLY. THE SURGEON INDICATED THAT NO OTHER INTERVENTION SUCH AS AN X-RAY WAS TAKEN TO RETRIEVE THE FRAGMENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGICAL STAFF INDICATED THAT A FRAGMENT FROM THE INSTRUMENT BROKE OFF, FELL INTO THE PATIENT, AND WAS RETRIEVED. THERE IS NO INDICATION THAT THE PATIENT WAS INJURED OR HARMED BECAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED UF/IMPORTER REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: ROBOTIC TOTAL ABDOMINAL HYSTERECTOMY IN PROGRESS WHEN SURGICAL TEAM NOTICED A SMALL BLACK OBJECT IN ABDOMINAL CAVITY, VISIBLE ON MONITOR. OBJECT WAS REMOVED AND INSPECTED; BLACK IN COLOR AND HARD TO THE TOUCH. TECH REMOVED INSTRUMENTS FROM TROCARS. A 5MM MONOPOLAR CAUTERY DEVICE REMOVED FROM 8MM DAVINCI TROCAR AND EXAMINED. OUTER, BLACK COVERING OF DEVICE HAD AN APPROXIMATELY 1.5MM AREA ON SHEATH THAT WAS FRAYED AND DAMAGED. ABDOMEN WAS IRRIGATED AND SUCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350361 MONOPOLAR CAUTERY INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420142-04 S10110509 594

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR DA VINCI SI SURG SYS INST., ACCESSORIES, & ESU