BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 2022859 · Received March 17, 2011

    Report

    Report Number
    2955842-2011-00071
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 3, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE RIGHT BLADE WAS BROKEN OFF AND MISSING FROM THE INSTRUMENT. THE BLADE HAD FRACTURED AT THE CROSS SECTION OF THE GRIP CABLE CRIMP AND HALF OF THE CABLE CRIMP IS EXPOSED. THE FRACTURE PLANE OF THE BLADE IS NEARLY STRAIGHT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY PROCEDURE A PIECE OF THE MONOPOLAR CURVED SCISSORS INSTRUMENT FELL INTO THE PATIENT. THE PIECE WAS RETRIEVED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH AN INSTRUMENT OF THE SAME TYPE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. THE DELAY IN REPORTING IS THE RESULT OF AN ADMINISTRATIVE ERROR BY A COMPLAINT HANDLING TEAM MEMBER. THIS ERROR HAS BEEN ADDRESSED WITH THE APPLICABLE TEAM MEMBER.

    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 M10090915 623

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SYSTEM, ACCESSORIES & ESU