BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3778499 · Received April 29, 2014

    Report

    Report Number
    2955842-2014-02663
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    March 19, 2014
    Report Date
    April 2, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND INSTRUMENT PASSED THE ENGAGEMENT AND RECOGNITION TEST WHEN PLACED ON AN IN-HOUSE SYSTEM. THE INSTRUMENT MOVED WITH FULL RANGE OF MOTION. ADDITIONAL OBSERVATIONS NOT REPORTED BY SITE WERE: THE PITCH DOWN CABLE WAS FOUND TO BE FRAYED AT THE DISTAL CLEVIS HUB. THE SMALL FRAYED STRANDS STUCK OUT AT THE INSTRUMENT'S WRIST, MEASURING APPROXIMATELY .074. THE OTHER CABLES AT THE WRIST WERE NOT DAMAGED. IN ADDITION, THE DISTAL END OF THE MAIN TUBE HAD SCRATCH MARKS WITH MATERIAL REMOVAL. THE SCRATCHES WERE .182 - .042 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, A FRAYED PITCH 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 DURING A DA VINCI PROSTATECTOMY PROCEDURE, STAFF PHYSICIAN, AND ROBOTIC TEAM STATED THAT THE PROGRASP FORCEPS INSTRUMENT ENGAGED WITHOUT DIFFICULTY, BUT WAS SLOW OR DECREASED ROTATION AT TIP. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. NOTHING REPORTEDLY FELL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257882 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-10 M10140109 875

    Patients

    Seq Age Sex Outcome Treatment
    1