BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 2133038 · Received June 17, 2011

    Report

    Report Number
    2955842-2011-00187
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 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 WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THE TUBE EXTENSION TO BE BROKEN AND MISSING A .280 X .210 PIECE AT THE PROX CLEVIS INTERFACE. THE SCISSOR BLADES ARE INTACT AND THE CLEVIS IS DISLODGED FROM TUBE EXTENSION. EVIDENCE NOT CONCLUSIVE, BUT TUBE EXTENSION LIKELY BROKE DUE TO EXCESSIVE SIDE LOADING. ELECTRICAL CONTINUITY PASSED. NO OTHER DAMAGE FOUND. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS: HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY PROCEDURE, THE SITE OBSERVED THE TIP OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TO HAVE BROKEN. THE PIECE WAS IMMEDIATELY RETRIEVED AND THE INSTRUMENT WAS REPLACED BEFORE THE PLANNED SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT INCIDENT. THE PATIENT WAS REPORTED AS DOING WELL WITH NO POST OPERATIVE COMPLICATIONS.

    Devices

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

    Patients

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