BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMANENT CAUTERY SPATULA INSTRUMENT

    MDR report key: 3953993 · Received July 23, 2014

    Report

    Report Number
    2955842-2014-04511
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 1, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS FOUND THAT THE A PIECE MEASURING APPROXIMATELY .126 WAS COMPLETELY BROKEN OFF THE CERAMIC SLEEVE, THE BROKEN PIECE DID NOT COME BACK WITH THE INSTRUMENT. THE EVIDENCE WAS INCONCLUSIVE, BUT THE DAMAGE WAS LIKELY 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. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: A PIECE OF THE PERMANENT CAUTERY SPATULA INSTRUMENT ALLEGEDLY BROKE OFF AND IT IS UNKNOWN IF A FRAGMENT REMAINED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PERMANENT CAUTERY SPATULA INSTRUMENT CERAMIC TIP WAS NOT ON THE SPATULA WHEN CHECKED AFTER A DA VINCI SURGICAL PROCEDURE. IT IS UNKNOWN IF IT FELL INTO THE PATIENT. ON (B)(6) 2014, AN ISI REPRESENTATIVE CONTACTED THE SITE TO REQUEST ADDITIONAL INFORMATION REGARDING THE REPORTED COMPLAINT. IT WAS INDICATED THAT THE PERMANENT CAUTERY SPATULA WAS FOUND MISSING A SMALL PIECE OF THE SPATULA FOLLOWING A DA VINCI HYSTERECTOMY PROCEDURE. THE SURGEON DECIDED NOT TO PERFORM POST-OPERATIVE (X-RAY OR ULTRASOUND) TESTS. IT IS UNKNOWN WHETHER A FRAGMENT REMAINED IN THE PATIENT AND IT WAS UNKNOWN WHETHER IT WAS DISCLOSED TO THE PATIENT. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE. THE PLANNED PROCEDURE WAS COMPLETED AND THE PATIENT RECOVERED AS EXPECTED. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL WITH ANY POST-OP COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431373 PERMANENT CAUTERY SPATULA INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420184-06 N10140324 477

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention