BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMANENT CAUTERY SPATULA INSTRUMENT

    MDR report key: 3920301 · Received July 8, 2014

    Report

    Report Number
    2955842-2014-04158
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    May 31, 2014
    Report Date
    June 9, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED TO INTUITIVE SURGICAL, INC. (ISI) AND EVALUATED. THE CERAMIC SLEEVE OF THE DISTAL END OF THE INSTRUMENT WAS FOUND TO BE BROKEN. THE BROKEN FRAGMENT(S) THAT RESULTED FROM THIS DAMAGE WERE NOT RETURNED WITH THE INSTRUMENT. FAILURE ANALYSIS INVESTIGATION CONCLUDED THAT THE INSTRUMENT DAMAGE MIGHT HAVE BEEN DUE TO LIKELY 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. ISI HAS ATTEMPTED TO CONTACT THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: A FRAGMENT FROM THE PERMANENT CAUTERY SPATULA INSTRUMENT BROKE OFF, FELL INTO THE PATIENT, AND WAS NOT RETRIEVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PULMONARY LOBECTOMY PROCEDURE, THE SURGEON INDICATED THAT THE COVER BELOW THE TIP OF THE PERMANENT CAUTERY SPATULA INSTRUMENT CRACKED AND FELL INTO THE PATIENT. THE INITIAL REPORTER OF THIS COMPLAINT INDICATED THAT THE FRAGMENT WAS NOT RETRIEVED. NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397506 PERMANENT CAUTERY SPATULA INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420184-06 S10130731 360

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention