BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOT SHEARS (TM) (MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3092909 · Received May 3, 2013

    Report

    Report Number
    2955842-2013-01544
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 8, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Removal / Correction Number
    2955842-051613-005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING WAS UNABLE TO CONFIRM THE FAILURE MODE. ENGINEERING PLACED THE INSTRUMENT ON THE DA VINCI ROBOT SYSTEM FOR A LATEX CUT TEST. THE INSTRUMENT WAS ABLE TO CUT CLEANLY THROUGH (B)(4) LATEX. THE BLADES WERE NOT DAMAGED. INSTRUMENT PASSED ELECTRICAL CONTINUITY TEST. ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS A CRACK ON THE MAIN TUBE. ENGINEERING OBSERVED THAT THE INSTRUMENT EXHIBITED A CRACK ON THE EXTENSION TUBE SIDE ABOUT 0.350 FROM THE EXTENSION TUBE. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED FOR RETROSPECTIVE ACTIVITY PERFORMED RELATING TO FIELD ACTION NUMBER (B)(4) TO INVESTIGATE MICRO-CRACKS ON THE MONOPOLAR CURVED SCISSORS INSTRUMENT. THESE TYPES OF MICRO-CRACKS WILL NOT LEAD TO MECHANICAL FAILURE OF THE INSTRUMENT; HOWEVER, THERE IS A POTENTIAL FOR INSULATION FAILURE AFTER REPROCESSING, RESULTING IN A PATHWAY FOR ELECTROSURGICAL ENERGY TO LEAK TO TISSUE AND POTENTIALLY CAUSE UNINTENDED INJURIES. THE LOCATION OF THESES MICRO-CRACKS IS CONFINED TO (B)(4) OF THE DISTAL END OF THE INSTRUMENT SHAFT. THIS INSTRUMENT WAS INSPECTED AS PART OF THIS RETROSPECTIVE ACTIVITY AND FOUND TO CONTAIN CRACKS ON THE INSTRUMENT MAIN TUBE. THESE CRACKS WERE REPORTED ON THE INITIAL MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI SURGICAL PROCEDURE, THE CUSTOMER NOTED THAT THE MONOPOLAR CURVED SCISSORS WERE DULL. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194524 HOT SHEARS (TM) (MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M11130211 428

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIE