BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 1914617 · Received December 3, 2010

    Report

    Report Number
    2955842-2010-00529
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Report Date
    November 5, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE INSTRUMENT WAS RETURNED WITH A PIECE OF THE LEFT BLADE BROKEN. THE BROKEN PIECE WAS NOT RETURNED. THE BLADE FRACTURED AT THE CROSS SECTION OF THE GRIP CABLE CRIMP AND HALF OF THE CABLE CRIMP IS EXPOSED. THE FRACTURE PLANE OF BLADE IS NEARLY STRAIGHT. NO OTHER DAMAGE FOUND.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SURGICAL PROCEDURE, ONE OF THE BLADES ON THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT BROKE OFF AND FELL INTO THE PATIENT. NO ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-09 M10100212 224

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SURG SYS, ACCESS AND AN ESU