BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3130953 · Received May 24, 2013

    Report

    Report Number
    2955842-2013-01847
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    September 12, 2011
    Report Date
    September 21, 2011
    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 Occupation
    OTHER

    Narratives

    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. ENGINEERING EVALUATION WAS UNABLE TO FIND ANY EVIDENCE OF ARCING OR MELTED MATERIALS. THE INSTRUMENT WAS PLACED ON AN IN HOUSE TEST SYSTEM FOR PERFORMANCE TESTING AND NO TROUBLE WAS FOUND. THE TIP COVER ACCESSORY USED IN CONJUNCTION WITH THE MCS INSTRUMENT DURING THE PROCEDURE WAS DISCARDED BY THE HOSPITAL AND WILL NOT BE RETURNED. ADDITIONALLY, THIS EVENT WAS INITIALLY REPORTED VIA MEDWATCH REPORT NUMBER 2955842-2011-00330 ON (B)(4) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A SUCCESSFUL DA VINCI SI PROSTATECTOMY PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL EXPERIENCING COMPLICATIONS. IT WAS DISCOVERED THAT THE PATIENT HAD A PERFORATION IN HIS RIGHT COLON, APPROXIMATELY 6 CM FROM THE CAECUM. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS INSPECTED PRIOR TO USE. ADDITIONALLY, NO COMPLICATIONS WERE OBSERVED BY THE SURGEON OR OPERATING ROOM STAFF WITH THE MCS INSTRUMENT OR THE MCS TIP COVER ACCESSORY DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232208 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M10110425 234

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SURG SYST., MCS TIP CVR, ACCSS & ESU.