BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 1952946 · Received January 7, 2011

    Report

    Report Number
    2955842-2011-00005
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    November 12, 2010
    Report Date
    December 13, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MCS INSTRUMENT AND TIP COVER ACCESSORY WERE RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT ENGINEERING FOUND NO VISUAL EVIDENCE OF ARCING OR CHAR MARKS ON THE INSTRUMENT. THE INSTRUMENT WAS INSPECTED AND FOUND TO PASS ELECTRICAL CONTINUITY TESTING AND DID NOT HAVE ANY BURRS OR ABNORMALLY SHARP EDGES THAT COULD CONTRIBUTE TO ARCING. VISUAL INSPECTION OF THE TIP COVER ACCESSORY SHOWED NO THERMAL OR MECHANICAL DAMAGE TO THE SILICONE. ON (B)(6) 2010 (B)(6) REPORTED THAT THE INSTRUMENT AND ACCESSORY WERE INSPECTED PRIOR TO USE AND AFTER REMOVED FROM THIS PROCEDURE, HOWEVER, NO EVIDENCE OF MALFUNCTION COULD BE FOUND. THE ESU SETTING USED WAS NOTED TO BE WITHIN ISI'S RECOMMENDED RANGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE SPARKING WAS SEEN COMING FROM THE TIPS OF THE MONOPOLAR CURVED SCISSORS INSTRUMENT WITH THE TIP COVER ACCESSORY INSTALLED. THE SURGEON DECIDED TO CONTINUE WITH THE CASE, HOWEVER SHORTLY AFTER A SECOND SPARKING EVENT WAS NOTICED. AT THIS TIME THE SURGICAL STAFF REMOVED THE MONOPOLAR CURVED SCISSORS INSTRUMENT AND TIP COVER ACCESSORY AND REPLACED THEM WITH ANOTHER INSTRUMENT AND ACCESSORY OF THE SAME TYPE. 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
    1 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M10101006 853

    Patients

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