BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3864248 · Received June 10, 2014

    Report

    Report Number
    2955842-2014-03560
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 13, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS INSPECTED THE INSTRUMENT UNDER DIGITAL MICROSCOPE AND NO DAMAGED WIRES WERE FOUND. FAILURE ANALYSIS ALSO OBSERVED THAT THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE TUBE ABRASIONS, FOUND DURING FAILURE ANALYSIS EVALUATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WIRES AT THE WRIST WERE NOTED TO BE KINKED PRIOR TO STARTING A DA VINCI HYSTERECTOMY PROCEDURE. NO FRAGMENTS FELL INTO THE PATIENT, NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338157 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 N10131109 931

    Patients

    Seq Age Sex Outcome Treatment
    1