BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ,MONOPOLAR CAUTERY SINGLESITEINSTRUMENT

    MDR report key: 3018372 · Received March 22, 2013

    Report

    Report Number
    2955842-2013-00957
    Event Type
    Malfunction
    Date Received
    March 22, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112208
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE INSTRUMENT WAS FOUND WITH BENT PRONGS AT THE CUATERY ADAPTER, CAUSING DIFFICULTY TO INSTALL THE ACCESSORY TIP. ENGINEERING CONCLUDED THAT THE DAMAGE WAS LIKELY DUE TO MISHANDLING WHILE INSTALLING THE ACCESSORY TIP. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT. THE SINGLE SITE 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 SI SURGICAL PROCEDURE, THE CUSTOMER NOTED THAT AT THE TIP OF THE MONOPOLAR CAUTERY SINGLE SITE INSTRUMENT WIRES WERE COMING OUT OF THE INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120327 ,MONOPOLAR CAUTERY SINGLESITEINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 428052-06 S10120926 677

    Patients

    Seq Age Sex Outcome Treatment
    1 DAVINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIES