BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3873181 · Received June 13, 2014

    Report

    Report Number
    2955842-2014-03653
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 19, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    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 FOUND THAT THE INSTRUMENT DID NOT HAVE BROKEN, FRAYED, LOOSE, OR DAMAGED WIRES AT THE TIP. FAILURE ANALYSIS ALSO OBSERVED THAT THE MAIN TUBE HAD SCRATCH MARKS THROUGHOUT THE LENGTH OF THE MAINTUBE. HOWEVER, THERE WERE MUCH LARGER SCRATCH MARKS NEAR THE DISTAL END. THE SCRATCH MARKS WERE BOTH ALIGNED AND MISALIGNED WITH THE MAIN TUBE. THERE WAS MATERIAL REMOVED. 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 PRECISE BIPOLAR FORCEPS INSTRUMENT CABLE WAS NOTED TO HAVE A BROKEN WIRE. IT IS UNKNOWN WHEN THE DAMAGE OCCURRED. NO MISSING OR FALLEN PIECES WERE REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351110 PRECISE BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420110-05 M10090903 494

    Patients

    Seq Age Sex Outcome Treatment
    1