BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC CURVED SHEARSINSERT ACCESSORY

    MDR report key: 1920322 · Received December 10, 2010

    Report

    Report Number
    2955842-2010-00546
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    October 22, 2010
    Report Date
    November 11, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K011281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSERT ACCESSORY WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE CLAMP ARM WAS DETACHED FROM THE DISTAL END. THE CLAMP ARM WAS NOT RETURNED. ONE SIDE OF THE SHAFT FEATURES AT THE DISTAL END THAT MATES WITH THE CLAMP ARM PINS IS BENT BACKWARDS. THE DAMAGE APPEARS TO BE CONSISTENT WITH HYPEREXTENSION OF THE CLAMP ARM AND ENGINEERING CONCLUDED THAT THE BREAKAGE WAS MOST LIKELY CAUSED BY MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL 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. DO NOT ATTEMPT TO BEND, SHARPEN, OR OTHERWISE ALTER THE SHAPE OF THE BLADE. DOING SO MAY CAUSE BLADE FAILURE AND USER OR PATIENT INJURY. AVOID CONTACT WITH ANY AND ALL METAL OR PLASTIC INSTRUMENTS OR OBJECTS WHEN THE INSTRUMENT IS ACTIVATED. CONTACT WITH STAPLES, CLIPS, OR OTHER INSTRUMENTS WHILE THE INSTRUMENT IS ACTIVATED MAY RESULT IN CRACKED OR BROKEN BLADES, WHICH MAY BE IDENTIFIED BY A GENERATOR SOLID TONE OR AN INSTRUMENT ERROR. CARE SHOULD BE TAKEN NOT TO APPLY PRESSURE BETWEEN THE BLADE AND CLAMP ARM WITHOUT HAVING TISSUE BETWEEN THEM. THIS CAN RESULT IN POSSIBLE DAMAGE TO THE INSTRUMENT. BOTH CONDITIONS MAY CAUSE A SYSTEM FAILURE SIGNALED BY A CONTINUOUS BEEP WHEN EITHER OF THE FOOT PEDALS IS DEPRESSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S SIGMOID RESECTION PROCEDURE, A PIECE OF THE TIP ON THE HARMONIC CURVED SHEARS INSERT (HCS) ACCESSORY BROKE OFF AND FELL INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED 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 SHEARSINSERT ACCESSORY ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400169-07

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR DA VINCI SI SYSTEM, INSTRUMENTS AND AN ESU