BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRRUMENT

    MDR report key: 3212181 · Received July 8, 2013

    Report

    Report Number
    2955842-2013-02477
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 11, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THERE WAS A MISSING BIPOLAR INSERT FROM THE BACK END OF THE INSTRUMENT, LEAVING THE PINS AND CONDUCTOR WIRES STICKING OUT OF THE CHASSIS. ADDITIONAL OBSERVATION NOT REPORTED BY THE CUSTOMER WAS MAIN TUBE DAMAGE. THE DISTAL END OF MAIN TUBE HAD TWO SMALL SCRATCH MARKS EXHIBITING LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. SCRATCHES WERE SHORT IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. ELECTRICAL CONTINUITY TESTING PASSED. NO OTHER DAMAGE WAS FOUND. EVIDENCE NOT CONCLUSIVE, BUT MAIN TUBE DAMAGE MAY BE DUE TO MISHANDLING. THE INSTRUMENTS AND 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 MAIN TUBE DAMAGE FOUND DURING FAILURE ANALYSIS COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF TO REOCCUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI S SURGICAL PROCEDURE, THE USER FACILITY IDENTIFIED A LOOSE BIPOLAR CONNECTION PART ON THE MARYLAND BIPOLAR FORCEPS INSTRUMENT. NO MISSING OR FALLEN PIECES WERE REPORTED. 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
    309392 MARYLAND BIPOLAR FORCEPS INSTRRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10121207 115

    Patients

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