BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3107903 · Received May 10, 2013

    Report

    Report Number
    2955842-2013-01626
    Event Type
    Malfunction
    Date Received
    May 10, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 12, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING CONFIRMED THE FLUSH PORT WAS STUCK AND WOULD NOT COME BACK UP. THE INSTRUMENT WAS RETURNED WITH A LUER FITTING ATTACHED TO THE LUER PLATE AT THE PRIMARY FLUSH PORT. THE LUER FITTING WAS STUCK AND COULD NOT BE REMOVED BY APPLYING AXIAL AND TWISTING FORCES. THE LUER FITTING WAS THE INCORRECT SIZE FOR LUER PLATE. ENGINEERING CONCLUDED THE ISSUE WAS LIKELY DUE TO IMPROPER CLEANING. AN ADDITIONAL OBSERVATION NOT REPORTED BY THE SITE WAS TUBE DAMAGE. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .070 - .130 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. ENGINEERING CONCLUDED THE DAMAGE MAY HAVE BEEN CAUSED BY MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS - HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP. 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 REPROCESSING THE FLUSH PORT WAS STUCK AND WOULD NOT COME BACK UP. THERE WERE NO MISSING PIECES OR FALLEN PIECES REPORTED. NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206078 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10120927 046

    Patients

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