BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3233264 · Received July 18, 2013

    Report

    Report Number
    2955842-2013-02610
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 19, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE REPORTED COMPLAINT. ONE GRIP CLOSE CABLE WAS BROKEN AT THE DISTAL IDLERS. THE IDLER PULLEY SPUN FREELY AND DID NOT EXHIBIT DAMAGE. THE CABLE SEGMENT STUCK OUT AT THE INSTRUMENT'S WRIST. THE CABLE BROKE UNDER TENSILE LOADING. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. ADDITIONAL OBSERVATION NOT REPORTED BY THE SITE WAS REMOVED PAD PRINTING. THE TUBE EXTENSION HAD THREE SCRATCH MARKS ON ONE SIDE EXHIBITING PAD PRINTING REMOVAL. THE SCRATCHES WERE .150 -230 LONG. EVIDENCE NOT CONCLUSIVE, BUT DAMAGE WAS LIKELY 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. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE TUBE ABRASIONS WITH PAD PRINTING 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, FRAYED CABLES WERE AT THE DISTAL END OF A MONOPOLAR CURVED INSTRUMENT. 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
    334487 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M12130109 835

    Patients

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