BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CAUTERY NSTRUMENT

    MDR report key: 3173878 · Received June 17, 2013

    Report

    Report Number
    2955842-2013-02198
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112208
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. RECEIVED THE INSTRUMENT INVOLVED WITH THE COMPLAINT. ENGINEERING CONFIRMED A BROKEN MONOPOLAR ADAPTER AT THE DISTAL END. THE ADAPTER HAD PIECES MISSING, WHICH WAS EXPOSING THE ELECTRICAL CONTACT. THE INTACT SECTION OF THE ADAPTER AND THE METAL PIECE BELOW IT BOTH EXHIBITED VARIOUS SCRATCH AND GOUGE MARKS. NO OTHER DAMAGE FOUND. EVIDENCE NOT CONCLUSIVE, BUT DAMAGE IS LIKELY DUE TO MISHANDLING/MISUSE. THE INSTRUMENTS & ACCESSORIES 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE, THE TIP OF THE MONOPOLAR CAUTERY INSTRUMENT BROKE WHEN THE SURGICAL TECH TRIED TO STRAIGHTEN OUT THE TIP. NOTHING REPORTEDLY FELL INTO THE PATIENT SINCE THE INSTRUMENT WAS NOT INSIDE THE PATIENT. THE INSTRUMENT WAS NOT USED ON A PATIENT AFTER THE REPORTED ISSUE WAS IDENTIFIED AND THERE WAS NO ALLEGATION OF HARM OR INJURY TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274387 MONOPOLAR CAUTERY NSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 428052-06 S10130403 551

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS, ACCESSORIES, ESU