BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOT SHEARS MONOPOLARCURVED SCISSORS INSTRUMENT

    MDR report key: 2944621 · Received February 5, 2013

    Report

    Report Number
    2955842-2013-00382
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    December 26, 2012
    Report Date
    January 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE ALLEGED COMPLAINT OF THE TIP COVER BEING HARD TO REMOVE AND THAT THE INSTRUMENT'S JAWS WERE DAMAGED COULD NOT BE CONFIRMED. THE INSTRUMENT WAS RETURNED WITH THE TIP COVER INSTALLED. THE TIP COVER WAS ABLE TO BE REMOVED EASILY WITH A TWISTING MOTION. FRICTION BETWEEN THE TIP COVER AND TUBE EXTENSION WAS NOT EXCESSIVE. A VISUAL INSPECTION OF THE INSTRUMENT REVEALED NO DAMAGE TO THE BLADES. THE INSTRUMENT BLADES WERE ABLE TO OPEN/CLOSE FINE WHEN INPUTS WERE MANUALLY ROTATED. AM ADDITIONAL OBSERVATION NOT REPORTED BY THE SITE WAS TUBE DAMAGE. THE DISTAL END OF THE INSTRUMENT'S MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .070 - .090 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. ENGINEERING CONCLUDED THAT THE DAMAGE MIGHT HAVE BEEN CAUSED BY MISHANDLING/MISUSE. NO OTHER INSTRUMENT DAMAGE WAS FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS - HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER THE REPORTED MALFUNCTION IF TO RECUR 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 (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 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.

    Description of Event or Problem · 1

    IT WAS OBSERVED DURING CENTRAL PROCESSING THAT THE TIP COVER OF THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS HARD TO REMOVE. DUE TO THE DIFFICULTY OF REMOVING THE TIP COVER, THE SITE THOUGHT THE INSTRUMENT'S JAWS WERE DAMAGED. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THERE WAS NO ALLEGATION OF ANY HARM, INJURY, OR ADVERSE OUTCOME TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47581 HOT SHEARS MONOPOLARCURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M11121105 392

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SURGICAL SYSTEM, ACCESSORIES, AND ESU