BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3878611 · Received June 17, 2014

    Report

    Report Number
    2955842-2014-03704
    Event Type
    Malfunction
    Date Received
    June 17, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 22, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS WAS NOT ABLE VERIFY THE COMPLAINT. THE INSTRUMENT COULD NOT BE TESTED DUE TO BROKEN TUBE EXTENSION AT THE DISTAL END. VISUAL INSPECTION WAS NOT ABLE TO CONFIRM THE COMPLAINT. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING DAMAGES, WHICH WERE NOT REPORTED: THE TUBE EXTENSION WAS BROKEN AT THE TUBE EXTENSION AND CLEVIS INTERFACE AND WAS MISSING A PIECE MEASURING APPROXIMATELY .301 X .281. THE CLEVIS WAS DISLODGED FROM THE TUBE EXTENSION. TUBE EXTENSION FRACTURED NEXT TO ONE OF THE KEYS THAT MATE WITH THE PROXIMAL CLEVIS. TUBE HAD A SCRATCH MARK THAT ALIGNS WITH THE REINFORCEMENT RING AND MAIN TUBE DAMAGE. FAILURE ANALYSIS CONCLUDED THAT BOTH OF THE DAMAGES WERE LIKELY DUE TO MISHANDLING. THE TUBE REINFORCEMENT RING HAD SCRATCH MARK MEASURING APPROXIMATELY .135 THAT ALIGNED WITH THE TUBE EXTENSION DAMAGE AND THE MAIN TUBE DAMAGE. THE DISTAL END OF THE MAIN TUBE HAD A SCRATCH MARK WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .153 - .089 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. 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. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE MATERIAL REMOVAL FROM THE MAIN TUBE FOUND DURING FAILURE ANALYSIS COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS DULL. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. NOTHING REPORTEDLY FELL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354180 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-12 N10140204 800

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR