BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 4028426 · Received August 21, 2014

    Report

    Report Number
    2955842-2014-05114
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    July 28, 2014
    Report Date
    August 4, 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 FOUND THAT THE INSTRUMENT HAD NO BROKEN, FRAYED, LOOSE, OR OTHERWISE DAMAGED CABLES AT THE TIP. FAILURE ANALYSIS ALSO OBSERVED THAT THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .050 - .143 IN LENGTH AND 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 WITH MATERIAL REMOVED, 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 PROGRASP INSTRUMENT CABLES WERE BROKEN. 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
    506916 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-11 N10140430 103

    Patients

    Seq Age Sex Outcome Treatment
    1