BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3203395 · Received July 2, 2013

    Report

    Report Number
    2955842-2013-02396
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 4, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING DID NOT CONFIRM THE ALLEGED COMPLAINT. THE INSTRUMENT WAS PLACED ON AN IN HOUSE DA VINCI IS3000 SYSTEM AND DRIVEN. RECOGNITION AND ENGAGEMENT TEST PASSED. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. ADDITIONAL OBSERVATIONS NOT REPORTED BY THE CUSTOMER WAS MAIN TUBE SCRATCHES. THE DISTAL END OF MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. SCRATCHES WERE 0.120 - 0.175 IN LENGTH AND WERE NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE FOUND. EVIDENCE NOT CONCLUSIVE, BUT MAIN TUBE DAMAGE MAY BE DUE TO MISHANDLING. THE INSTRUMENTS & ACCESSORIES 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 MAIN TUBE DAMAGE FOUND DURING FAILURE ANALYSIS IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE USER FACILITY HAD A HARD TIME OPENING THE PROGRASP FORCEPS INSTRUMENT. NOTHING REPORTEDLY FELL INTO A PATIENT. 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
    302034 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10130419 102

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES