BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND DISSECTOR INSTRUMENT

    MDR report key: 3945445 · Received July 21, 2014

    Report

    Report Number
    2955842-2014-04411
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 24, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND A BROKEN SNAKE WRIST CABLE AT THE DISTAL END. THE CABLE STUCK OUT AT THE WRIST APPROXIMATELY .179. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE BROKEN CABLE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MARYLAND DISSECTOR INSTRUMENT USED DURING THE TONSILLECTOMY PROCEDURE WAS NORMAL BEFORE THE START OF THE PROCEDURE BUT DURING THE PROCEDURE THE METAL STRINGS INSIDE THE INSTRUMENT WRIST WERE BROKEN AND THEY APPEARED OUTWARDLY. THIS WAS OBSERVED AND THE INSTRUMENT WAS REMOVED AND KEPT ASIDE. NO INSTRUMENT DEBRIS FELL INTO THE PATIENT AND ALSO NO DAMAGE OCCURRED TO THE PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425206 MARYLAND DISSECTOR INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420143-04 S10121205 161

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR