BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCHERTEL GRASPER INSTRUMENT

    MDR report key: 3073513 · Received April 23, 2013

    Report

    Report Number
    2955842-2013-01352
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    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. ENGINEERING COULD NOT CONFIRM THE ALLEGED BROKEN TIP SCISSORS COMPLAINT SINCE THIS INSTRUMENT IS A GRASPER AND NOT A SCISSORS INSTRUMENT. THE INSTRUMENT'S GRIPS OPENED AND CLOSED AS EXPECTED WHEN THE INPUT DISC WAS MANUALLY ROTATED. NO VISIBLE DAMAGE WAS NOTED FOR THE INSTRUMENT'S SNAKE WRIST OR GRIPS. ADDITIONAL OBSERVATION NOT INITIALLY REPORTED BY THE SITE WAS MAIN TUBE INSULATION DAMAGE. THE INSULATION WAS GOUGED IN A COUPLE OF PLACES AT THE DISTAL END AND HAD A SECTION THAT WAS LIFTED UP ROUGHLY 0.650 ABOVE THE INSTRUMENT'S SNAKE WRIST. NO PIECES WERE MISSING SINCE THE LIFTED UP PIECE FULLY COVERED THE EXPOSED SECTION OF THE SHAFT. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    DURING CENTRAL PROCESSING, THE USER FACILITY REPORTEDLY IDENTIFIED BROKEN TIP SCISSORS FROM THE SCHERTEL GRASPER INSTRUMENT . THE INSTRUMENT REPORTEDLY WAS NOT USED ON A PATIENT AFTER THE REPORTED ISSUE WAS IDENTIFIED AND THERE WAS NO ALLEGATION OF HARM OR INJURY TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174390 SCHERTEL GRASPER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420139-04 S10120113 910

    Patients

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