BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3382451 · Received October 2, 2013

    Report

    Report Number
    2955842-2013-03937
    Event Type
    Malfunction
    Date Received
    October 2, 2013
    Date of Event
    August 16, 2013
    Report Date
    September 4, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED COMPLAINT. THE BLADES OPENED AFTER THE INPUT DISKS WERE ROTATED. WHEN INITIALLY CONDUCTING THE FAILURE ANALYSIS, SOME RESIDUE WAS NOTICED ON THE ENDS OF THE BLADES. A TOOL WAS USED TO TEST THE RESIDUE FOR ADHERENCE AFTER THIS TEST WAS CONDUCTED, MOST OF THE RESIDUE WAS CLEANED OFF THE BLADES. AN ADDITIONAL FINDING WAS VARIOUS SCRATCHES ON THE DISTAL END OF THE MAIN TUBE SHOWING LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCHES WERE .150 - .423 IN LENGTH AND BOTH ALIGNED AND NOT AXIALLY ALIGNED WITH THE TUBE. FAILURE ANALYSIS CONCLUDED THE DAMAGE MAY BE DUE TO MISHANDLING / MISUSE. NO OTHER DAMAGE WAS FOUND. 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. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; TUBE ABRASIONS WITH MATERIAL REMOVED ,FOUND DURING FAILURE ANALYSIS EVALUATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REPROCESSING, THE JAWS OF A MONOPOLAR CURVED SCISSORS INSTRUMENT WOULD NOT OPEN WHEN THEY TRIED TO CLEAN THEM. THERE WERE NO MISSING PIECES OR FALLEN PIECES REPORTED. NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499011 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-12 M12130702 311

    Patients

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