BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOUBLE FENESTRATED GRASPER INSTRUMENT

    MDR report key: 3000705 · Received March 12, 2013

    Report

    Report Number
    2955842-2013-00803
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING FOUND THE PITCH CABLE WAS BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP STILL REMAINED IN THE CLEVIS. THE CLEVIS DID NOT EXHIBIT EXCESSIVE DAMAGE. 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

    THE DOUBLE FENESTRATED GRASPER INSTRUMENT WAS RETURNED WITHOUT ANY SPECIFIC ALLEGATIONS OF MALFUNCTION. NO INFORMATION REGARDING THE DETAILS OF WHEN THE BREAKAGE OCCURRED WERE SPECIFIED. NO FURTHER INFORMATION WAS RECEIVED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103912 DOUBLE FENESTRATED GRASPER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420189-07 M10120522 826

    Patients

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