BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS

    MDR report key: 2830720 · Received November 13, 2012

    Report

    Report Number
    2955842-2012-00908
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 16, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT ONE GRIP CLOSE CABLE WAS FOUND TO BE DERAILED AT THE DISTAL IDLER PULLEY. THE DERAILED OF THE GRIP CABLE CREATED THE LOOSE CABLE THAT THE CUSTOMER OBSERVED. THE GRIPS WERE ABLE TO OPEN AND CLOSE, BUT THEIR MOVEMENT COULD NOT BE PRECISE. THE CABLE DERAILMENT WAS LIKELY DUE TO CABLE LOSING CONTACT WITH PULLEY DURING WRIST ARTICULATION. FLEET ANGLE BETWEEN PROXIMAL AND DISTAL PULLEYS COULD HAVE CONTRIBUTED TO THE DERAILMENT. INSTRUMENT PASSED ELECTRICAL CONTINUITY TEST. ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS A FRAYED GRIP CABLE. SAME DERAILED CABLE WAS ALSO FOUND TO BE FRAYED AT THE DISTAL IDLER PULLEY. THE FRAYED STRANDS STICK OUT AT THE WRIST. 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

    IT WAS REPORTED THAT DURING CLEANING AND STERILIZATION, THE CUSTOMER NOTED A LOOSE CABLE ON THE MARYLAND BIPOLAR FORCEPS INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARYLAND BIPOLAR FORCEPS ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10100517 240

    Patients

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