BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORSINSTRUMENT

    MDR report key: 3191407 · Received June 26, 2013

    Report

    Report Number
    2955842-2013-02308
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 29, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE REPORTED COMPLAINT WITH THE FOLLOWING CLARIFICATION, THE BLADE WAS DAMAGED. THE SCISSORS DIDN'T FULLY CLOSE DUE TO BLADE DAMAGE. AS A RESULT, THE BLADES DID NOT CUT THROUGH THEIR ENTIRE LENGTH AND A CUT TEST FAILS. ONE BLADE EDGE HAD AN INDENTATION NEAR THE MIDPOINT THAT ACTED AS A MECHANICAL STOP FOR THE OTHER BLADE WHEN CLOSING. ENGINEERING CONCLUDED THE DAMAGE TO THE BLADE WAS LIKELY DUE TO MISHANDLING/MISUSE. ADDITIONAL OBSERVATION NOT REPORTED WAS TUBE DAMAGE. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .080 - .145 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. ENGINEERING CONCLUDED THE DAMAGE MAY HAVE BEEN CAUSED BY 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 REMOVAL , 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 A MONOPOLAR CURVED SCISSORS INSTRUMENT, A CRACK ON THE LEFT SIDE OF THE GASPER WAS FOUND. 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
    291449 MONOPOLAR CURVED SCISSORSINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M10130130

    Patients

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