BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC CURVED SHEARS INSERTACCESSORY

    MDR report key: 2843212 · Received November 21, 2012

    Report

    Report Number
    2955842-2012-01058
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 25, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K011281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED FAILURE MODE. VISUAL INSPECTION SHOWS THE CLAMP ARM AND CURVED BLADE ARE STILL INTACT AND THE BLADE DOES NOT EXHIBIT CRACKING AT THE DISTAL END. THE CLAMP ARM CAN OPEN/CLOSE PROPERLY WHEN THE ROUND RACK FEATURE AT THE PROXIMAL END IS MANUALLY ACTUATED. ENGINEERING EVALUATION ALSO FOUND, THAT ONE CORNER OF THE TEFLON PAD HAS A SMALL GOUGE AT THE CHAMFERED EDGE. THERE IS A SMALL SEGMENT OF THE PAD THAT IS MISSING FROM THE DAMAGED AREA. THE SAME SIDE OF THE PAD IS LIFTED UP SLIGHTLY FROM THE CLAMP ARM. ENGINEERING CONCLUDED THAT THE DAMAGE IS LIKELY DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS O INSPECT THE TIP COVER ACCESSORY PERIODICALLY DURING USE. IF ANY DAMAGE OR TEARS ARE OBSERVED, REPLACE THE TIP COVER ACCESSORY WITH A NEW ONE. O DO NOT USE ANOTHER INSTRUMENT TO CLEAN THE TIP COVER ACCESSORY. O TO PREVENT DAMAGE TO THE TIP COVER ACCESSORY INSULATION, ALWAYS STRAIGHTEN THE INSTRUMENT WRIST UNDER ENDOSCOPIC VISUALIZATION BEFORE REMOVING THE INSTRUMENT THROUGH THE CANNULA O 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. ON (B)(6), 2012, THE INTUITIVE SURGICAL ACCOUNT MANAGER REPORTED THAT THE TIP PART ON THE HARMONIC ACE INSERT ACCESSORY DID NOT BREAK OFF DURING THE SURGICAL PROCEDURE; HOWEVER, IT BROKE OFF AND WAS LOST DURING THE CLEANING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI SURGICAL PROCEDURE, THE TIP PART ON THE HARMONIC CURVED SHEARS INSERT ACCESSORY INSTALLED ON THE HARMONIC CURVED SHEARS INSTRUMENT SLIPPED OUT. NO FRAGMENTS FROM THE HARMONIC ACE INSERT ACCESSORY FELL INTO THE PATIENT. THE INSERT ACCESSORY WAS REPLACED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED, NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC CURVED SHEARS INSERTACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400169-07 M10120515

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SURG SYSTEM, HARMONIC ACE INSTR & ESU