BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOT SHEARS (TM) MONOPOLARCURVED SCISSORS

    MDR report key: 2946088 · Received February 6, 2013

    Report

    Report Number
    2955842-2013-00422
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    December 11, 2012
    Report Date
    January 10, 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
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED FOR RETROSPECTIVE ACTIVITY PERFORMED RELATING TO FIELD ACTION NUMBER 2955842-051613-005 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 2 CM 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.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING PLACED THE INSTRUMENT ON AN IN-HOUSE SYSTEM FOR THE LATEX CUT TEST. SCISSORS DO NOT CUT CLEANLY THROUGH .006 LATEX. LATEX GETS SNAGGED AT SCISSOR TIPS. BLADE EDGES ARE NOT DAMAGED, BUT EDGES EXHIBIT WEAR AT THE TIPS, NEGATIVELY AFFECTING CUT PERFORMANCE. ELECTRICAL CONTINUITY PASSED. THE INSTRUMENT HAS 3 USES REMAINING. ADDITIONAL FINDINGS REVEALED THAT THE ORANGE PRINT FROM THE EXTENSION TUBE IS REMOVED. THE MISSING PRINT MEASURED ROUGHLY ABOUT 0.157 X 0.127. EVIDENCE NOT CONCLUSIVE BUT DAMAGE MOST LIKELY DUE TO IMPROPER CLEANING. PER THE CUSTOMER, AT THE TIME OF THE REPORTED EVENT, NOTHING FELL INTO A PATIENT DURING A SURGICAL PROCEDURE. THE CLEANING AND STERILIZATION USER MANUAL SPECIFICALLY STATES: WHEN SCRUBBING THE TIP OF CAUTERY INSTRUMENTS, TAKE CARE NOT TO DAMAGE THE INSULATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI PROSTATECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS DULL. THE INTENDED PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51191 HOT SHEARS (TM) MONOPOLARCURVED SCISSORS ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M11121016 254

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES