BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3872020 · Received June 13, 2014

    Report

    Report Number
    2955842-2014-03631
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 14, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE CUSTOMER REPORTED COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS. THE INSTRUMENT WAS CHECKED FOR RECOGNITION ON AN IS-3000 SYSTEM. THE SYSTEM SUCCESSFULLY RECOGNIZED THE INSTRUMENT. THE POGO PINS DO NOT STICK AND ARE NOT CONTAMINATED. ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS THE INSTRUMENT PITCH CABLE WAS BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN CLEVIS. THE CLEVIS DOES NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. ADDITIONALLY ON THE SURFACE OF THE DISTAL PULLEY THERE WERE SCRATCH MARKS/ABRASIONS. AN ADDITIONAL FINDING WAS VARIOUS SCRATCHES ON THE DISTAL END OF THE MAIN TUBE SHOWING LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCHES WERE SHORT IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. NO OTHER DAMAGE FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER BROKEN PITCH CABLE AND MAIN TUBE SCRATCHES WITH LIGHT MATERIAL REMOVAL WERE TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING DA VINCI PROCEDURE THE PROGRASP FORCEPS INSTRUMENT WAS NOT RECOGNIZED. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THERE WAS NO ALLEGATION OF ANY HARM, INJURY, OR ADVERSE OUTCOME TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349542 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10130910 905

    Patients

    Seq Age Sex Outcome Treatment
    1