BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3081332 · Received April 26, 2013

    Report

    Report Number
    2955842-2013-01420
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 28, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE REPORTED COMPLAINT. WHEN ARTICULATING THE INSTRUMENT MANUALLY, THE MOVEMENT WAS NOT PRECISE. THE ROLL INPUT AND PITCH INPUT DISC DID NOT MOVE SMOOTHLY WHEN MANUALLY ROTATED. VISUAL INSPECTION SHOWED THE FRONT ROLL AXIS BEARING AND THREE BEARINGS BELOW CLAMPING PULLEYS EXHIBITED CONTAMINATION THAT WAS POSSIBLY CAUSING INCREASED FRICTION. ENGINEERING CONCLUDED IMPROPER CLEANING MAY CONTRIBUTE TO ISSUE. ADDITIONAL DAMAGE FOUND WAS DEEP SCRATCHES ON THE MAIN TUBE. THE DISTAL END OF MAIN TUBE HAD A COUPLE SCRATCH MARKS EXHIBITING LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. ENGINEERING CONCLUDED THE DAMAGE WAS LIKELY DUE TO MISHANDLING. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI TOTAL BENIGN HYSTERECTOMY THE PROGRASP FORCEPS INSTRUMENT DID NOT HAVE A FULL RANGE OF MOTION. THERE WERE NO MISSING PIECES OR FALLEN PIECES 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
    181070 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10120919 204

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES