BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 MM MONOPOLAR CAUTERY INSTRUMENT

    MDR report key: 2781630 · Received October 10, 2012

    Report

    Report Number
    2955842-2012-00518
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 12, 2012
    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. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE MAIN TUBE INSULATION EXHIBITED DAMAGE ALONG THE ENTIRE MAIN TUBE. THE INSULATION WAS FOUND WITH SEVERAL GOUGE MARKS. THE MARKS WERE SHORT IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. MAIN TUBE ALSO EXHIBITED A COUPLE OF DIFFERENT DAMAGED SECTIONS WITH TUBE INSULATION REMOVED. ENGINEERING CONCLUDED THAT DAMAGE WAS LIKELY DUE TO MISHANDLING. INTUITIVE SURGICAL CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT. IT WAS INDICATED THAT NO PIECES FELL INSIDE THE PATIENT DURING THE LAST SURGICAL PROCEDURE THIS INSTRUMENT WAS USED. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL WITH ANY POST-SURGICAL COMPLICATIONS. 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. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DAVINCI SI TRANSANAL TUMOR RESECTION SURGERY, THE CUSTOMER REPORTED THAT 'THE BLACK COATING MAIN INSULATION WAS COMING OFF' ON THE MONOPOLAR CAUTERY INSTRUMENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5 MM MONOPOLAR CAUTERY INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420142-04 S10110415 126

    Patients

    Seq Age Sex Outcome Treatment
    1 DAVINCI SI SURG SYSTEM, INSTRUMENTS & ACCESSORIES