BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC CURVED SHEARS INSERT

    MDR report key: 2832446 · Received November 14, 2012

    Report

    Report Number
    2955842-2012-00923
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 18, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K042855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING OBSERVED THAT THE TEFLON PAD WAS ABLE TO SLIDE UP AND DOWN ON THE CLAMP ARM. NO PIECES OF PAD WERE MISSING. THE PAD COULD NOT BE PULLED OFF OF CLAMP ARM, IT WAS STILL RETAINED IN THE GROOVE. THE PAD WAS CHECKED AGAINST OTHER PADS ON OTHER INSERTS AND THIS PAD WAS SLIGHTLY NARROWER IN WIDTH, WHICH ALLOWS FOR GREATER TRAVEL UP AND DOWN THE CLAMP ARM. THE PAD WIDTH WAS STILL WITHIN SPECIFICATIONS. NO OTHER DAMAGE FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S SURGICAL PROCEDURE, 'THE WHITE COLORED PROTECTOR TIP' ON THE HARMONIC CURVED SHEARS INSTRUMENT WAS 'SHAKING UP AND DOWN.' NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC CURVED SHEARS INSERT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400169-07 M10120419

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESSORIES| DAVINCI S SYSTEM INSTRUMENTS