BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENACULUM FORCEPS INSTRUMENT

    MDR report key: 3241635 · Received July 22, 2013

    Report

    Report Number
    2955842-2013-02683
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 24, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING DID NOT FIND A LOOSE CABLE BUT FOUND A BROKEN PITCH UP CABLE AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. OTHER CABLES AT WRIST WERE NOT DAMAGED. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF TO REOCCUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE, THE USER FACILITY IDENTIFIED A LOOSE CABLE ON THE TENACULUM FORCEPS INSTRUMENT. NO MISSING OR FALLEN PIECES WERE REPORTED. THE INSTRUMENT 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
    341239 TENACULUM FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420207-06 M10121017 124

    Patients

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