BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3803120 · Received May 9, 2014

    Report

    Report Number
    2955842-2014-02896
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    March 13, 2014
    Report Date
    April 15, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    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 INVESTIGATION OBSERVED THAT THE INSTRUMENT'S TUBE EXTENSION WAS BROKEN AND MISSING A .187 X .215 PIECE AT THE PROXIMAL CLEVIS INTERFACE. THE CLEVIS WAS DISLODGED FROM TUBE EXTENSION. EVIDENCE NOT CONCLUSIVE, BUT TUBE EXTENSION LIKELY BROKE DUE TO EXCESSIVE SIDE LOADING OR OTHER MISHANDLING/MISUSE. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. AN ADDITIONAL OBSERVATION WAS THAT THE INSTRUMENT'S TUBE EXTENSION PAD PRINTING WAS REMOVED. EVIDENCE NOT CONCLUSIVE, BUT PAD PRINTING REMOVED DAMAGE MAY BE DUE TO LIKELY MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REPROCESSING OF THE MONOPOLAR CURVED SCISSORS INSTRUMENT THE CUSTOMER NOTED THAT THE SHEATH AT THE DISTAL TIP WAS CRACKED AND PEELING. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281843 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-12 M10140113 431

    Patients

    Seq Age Sex Outcome Treatment
    1