BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORSINSTRUMENT

    MDR report key: 3182995 · Received June 21, 2013

    Report

    Report Number
    2955842-2013-02260
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    January 9, 2013
    Report Date
    May 22, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Removal / Correction Number
    2955842-051613-005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING WAS UNABLE TO CONFIRM THE REPORTED FAILURE MODE. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM. THE SYSTEM SUCCESSFULLY RECOGNIZED INSTRUMENT. THE POGO PINS DID NOT STICK AND WERE NOT CONTAMINATED. ADDITIONAL DAMAGE FOUND WERE DEEP SCRATCHES AND CRACKS ON THE MAIN TUBE. THE DISTAL END OF THE MAIN TUBE HAD SCRATCH MARKS EXHIBITING LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCHES WERE SHORT IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. ENGINEERING CONCLUDED THE DAMAGE MAY BE DUE TO MISHANDLING. SEVERAL HAIRLINE CRACKS WERE ALSO FOUND NEAR THE TUBE EXTENSION ON THE DISTAL END. ELECTRICAL CONTINUITY TESTING WAS PERFORMED AND PASSED. 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 AND HAIRLINE CRACKS , 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 A DA VINCI SI NEPHRECTOMY PROCEDURE THE SYSTEM DID NOT RECOGNIZE THE MONOPOLAR CURVED SCISSORS INSTRUMENT. TESTED SEVERAL TIMES WITHOUT SUCCESS. NOTHING REPORTEDLY FELL INTO A PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282519 MONOPOLAR CURVED SCISSORSINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 S10090422 842

    Patients

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