BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMANENT CAUTERY SPATULA INSTRUMENT

    MDR report key: 3983305 · Received August 6, 2014

    Report

    Report Number
    2955842-2014-04742
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 8, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THE CERAMIC SLEEVE BROKEN WITH A PIECE MISSING MEASURING 0.039 X 0.059. NO OTHER DAMAGE WAS FOUND. FAILURE ANALYSIS CONCLUDED THE DAMAGE WAS LIKELY DUE TO MISHANDLING / MISUSE. 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. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: A PIECE OF THE PERMANENT CAUTERY SPATULA INSTRUMENT HAD FALLEN INTO THE PATIENT, AND AS A RESULT, X-RAYS WERE TAKEN. IT IS UNKNOWN IF THE FRAGMENT WAS REMOVED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, PART OF THE CERAMIC COLAR FROM THE PERMANENT CAUTERY SPATULA INSTRUMENT FELL INSIDE THE PATIENT AND WAS NOT RETRIEVED. AN XRAY WAS PERFORMED AND THEY COULD NOT FIND THE FRAGMENT. THERE WAS NO ALLEGATION OF HARM OR INJURY TO THE PATIENT. ON (B)(4) 2014, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE INITIAL REPORTER. SHE INDICATED THEY WERE AWARE THE CERAMIC COLLAR IS NOT RADIO OPAQUE BUT AN X-RAY WAS PREFORMED PER STANDARD PROCEDURE. NO INTEROPERATIVE COLLISIONS WERE REPORTED. SHE STATED AN ASSIST PORT CAME OUT SO THE PROCEDURE WAS PAUSED WITH INSTRUMENTS INSERTED, THE ASSIST PORT WAS PUT BACK IN PLACE AND WHEN THE SURGICAL FIELD WAS VISUALIZED AGAIN, A FRAGMENT WAS VISUALIZED. THE ASSIST PORT WAS THEN USED TO REMOVE THE FRAGMENT. THE FRAGMENT WAS PICKED UP BUT THEN DROPPED AND WAS UNABLE TO BE LOCATED AGAIN. THE AREA WAS THEN IRRIGATED AND SUCTIONED BUT IT WAS UNKNOWN IF THE FRAGMENT WAS SUCTIONED OUT. SHE INDICATED THE FRAGMENT WAS VERY SMALL. THE PATIENT HAS NOT RETURNED OR REPORTED ANY POST-OPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459447 PERMANENT CAUTERY SPATULA INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420184-06 M10140530 694

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other