BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3970331 · Received July 31, 2014

    Report

    Report Number
    2955842-2014-04631
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 22, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED COMPLAINT OF MONOPOLAR CORD BURNED THROUGH AT SITE OF ATTACHMENT. THE INSTRUMENT DID NOT SHOW ANY SIGNS OF ARCING. THE INSTRUMENT PASSED A CAUTERY TEST ON AN IN-HOUSE DA VINCI SYSTEM. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE DISTAL END OF THE INSTRUMENT'S MAIN TUBE HAD VARIOUS SCRATCH MARKS/ABRASIONS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES MEASURED APPROXIMATELY 0.053 - 0.171 IN LENGTH AND WERE NOT ALIGNED WITH THE TUBE AXIS. IN ADDITION, THE INSTRUMENT'S MAIN TUBE WAS CRACKED. THE TUBE HAD A SMALL FISSURE IN THE AXIAL DIRECTION. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE VARIOUS SCRATCH MARKS ON THE MAIN TUBE WITH LIGHT MATERIAL REMOVAL FOUND DURING FAILURE ANALYSIS IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MONOPOLAR CORD BURNED THROUGH AT SITE OF ATTACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448265 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-12 N10140422 975

    Patients

    Seq Age Sex Outcome Treatment
    1