BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8MM TIP COVER ACCESSORY

    MDR report key: 4250932 · Received November 14, 2014

    Report

    Report Number
    2955842-2014-05667
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 23, 2014
    Report Date
    October 28, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP COVER ACCESSORY WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION FOUND THERMAL DAMAGE IN TWO LOCATIONS ON THE TIP COVER. THE FIRST HOLE MEASURED ROUGHLY ABOUT 0.153 X 0.106 AND THE SECOND HOLE MEASURED ROUGHLY ABOUT 0.144 X 0.093. BOTH HOLES WERE IN AREAS WHERE CAUTERY ENERGY COULD POTENTIALLY ESCAPE. THERE WERE NO BROKEN OFF PIECES. EVIDENCE IS NOT CONCLUSIVE, HOWEVER, THE THERMAL DAMAGE WAS LIKELY DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE TIP COVER ARCING IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A DA VINCI HYSTERECTOMY SURGICAL PROCEDURE THAT THE MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY FELL OFF OF THE MONOPOLAR CURVED SCISSORS INSTRUMENT WHILE REMOVING A CYST FROM THE PATIENT. ON 10/29/2014, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT. THE INITIAL REPORTER CONFIRMED THAT THE TIP COVER ACCESSORY WAS REMOVED IN ONE PIECE AND THERE WERE TWO BURN HOLES IN DIFFERENT LOCATIONS. THE TIP COVER ACCESSORY WAS RETRIEVED LAPAROSCOPICALLY DURING THE SAME DA VINCI SURGICAL PROCEDURE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED TO RETRIEVE THE TIP COVER ACCESSORY. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST SURGICAL COMPLICATIONS AS A RESULT OF THE TIP COVER ACCESSORY FALLING INTO THE PATIENT. THERE WAS NO ADVERSE EVENT, HARM OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736742 8MM TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180-14 M10140630

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR