BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3810620 · Received May 14, 2014

    Report

    Report Number
    2955842-2014-02999
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 18, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION FOUND THE INSTRUMENTS REINFORCEMENT RING WAS BROKEN. THE PROXIMAL TUBE REINFORCEMENT RING WAS BROKEN. THE BROKEN FRAGMENT WAS NOT RETURNED WITH THE INSTRUMENT. FAILURE ANALYSIS CONCLUDED THAT THE BROKEN DAMAGE WAS DUE TO MISHANDLING/MISUSE. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE INSTRUMENTS MAIN TUBE WAS CRACKED. THE TUBE HAS A SMALL FISSURE IN THE AXIAL DIRECTION, LOCATED DIRECTLY BELOW THE TUBE REINFORCEMENT RING. THE LOCATION OF THE FISSURE WAS IN AN AREA THAT IS NOT PROTECTED BY THE TIP COVER. FAILURE ANALYSIS CONCLUDED THAT THE CRACKED DAMAGE WAS DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THERE WAS NO ADVERSE EVENT SINCE THE FRAGMENT WAS RETRIEVED LAPAROSCOPICALLY DURING THE SAME DA VINCI SURGICAL PROCEDURE AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE A FRAGMENT FROM THE MONOPOLAR CURVED SCISSORS BROKE OFF AND FELL INTO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DA VINCI SURGICAL PROCEDURE, THE SURGEON NOTICED A RING FROM THE MONOPOLAR CURVED SCISSORS (MCS)WAS IN THE PATIENTS ABDOMEN. THE NURSE DIDN'T NOTICE ANYTHING PARTICULAR WHEN INSTALLING THE TIP COVER ON THE MCS INSTRUMENT. WHEN THE INSTRUMENT WAS REMOVED, IT WAS OBSERVED THAT IT HAD DETERIORATED, AND THE RING WAS FOUND IN THE BODY OF THE PATIENT. ON (B)(4) 2014, INTUITIVE SURGICAL INC (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT. THE INITIAL REPORTER CONFIRMED THAT A FRAGMENT FROM THE MCS INSTRUMENT FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED LAPAROSCOPICALLY DURING THE SAME DA VINCI SURGICAL PROCEDURE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED TO RETRIEVE THAT FRAGMENT. 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 FRAGMENT FALLING INTO THE PATIENT. THERE WAS NO ADVERSE EVENT, HARM OR INJURY TO THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288556 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-12 M10140129 483

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR