BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3945761 · Received July 21, 2014

    Report

    Report Number
    2955842-2014-04419
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    April 4, 2014
    Report Date
    June 26, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND ONE OF THE BIPOLAR PIN WAS BROKEN AND MISSING. THE PIN WAS NOT RETURNED WITH THE INSTRUMENT. IN ADDITION, THE CONDUCTOR WIRE STUCK OUT AT THE BACKEND ON ITS OWN. FAILURE ANALYSIS CONCLUDED THAT THE BROKEN PIN DAMAGE WAS LIKELY DUE TO MISHANDLING. FAILURE ANALYSIS INVESTIGATION ALSO OBSERVED THE FOLLOWING UNREPORTED DAMAGES: THE BIPOLAR INSERT WAS MISSING FROM THE CHASSIS. THE INSERT WAS NOT RETURNED WITH THE INSTRUMENT. THE PITCH UP CABLE WAS FRAYED AT THE DISTAL CLEVIS HUB. THE FRAYED STRANDS STUCK OUT AT THE INSTRUMENT WRIST. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. NO OTHER DAMAGE WAS 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. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE FRAYED CABLE FOUND DURING FAILURE ANALYSIS COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI PROSTATECTOMY PROCEDURE, THERE WAS NO BIPOLAR CONNECTION, PRONGS WERE BROKEN OFF ON THE MARYLAND BIPOLAR FORCEPS INSTRUMENT. NOTHING FELL INTO THE PATIENT. 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
    426419 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10131107 873

    Patients

    Seq Age Sex Outcome Treatment
    1