BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3821766 · Received May 20, 2014

    Report

    Report Number
    2955842-2014-03103
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 24, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND A FRAYED PITCH CABLE AT THE DISTAL CLEVIS HUB. THE FRAYED STRANDS STUCK OUT AT THE INSTRUMENT'S WRIST. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. ADDITIONAL OBSERVATION NOT REPORTED WAS THE CONDUCTOR WIRE'S INSULATION WAS DAMAGED AND MISSING MATERIAL. THE ELECTRICAL CONTINUITY TEST WAS PERFORMED AND PASSED. THERE WERE NO SIGNS OF ARCING OBSERVED. NO OTHER DAMAGE WAS FOUND. FAILURE ANALYSIS CONCLUDED THAT THE INSULATION DAMAGE WAS LIKELY DUE TO MISHANDLING. 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. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE FRAYED CABLE AND THE MISSING CONDUCTOR WIRE INSULATION FOUND DURING FAILURE ANALYSIS COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTIONS WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SURGICAL PROCEDURE, BROKEN WIRES WERE IDENTIFIED ON A FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THE INSTRUMENT WAS NOT USED ON THE 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
    298304 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 N10140106 667

    Patients

    Seq Age Sex Outcome Treatment
    1