BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC CURVED SHEARS INSERT

    MDR report key: 1133557 · Received August 22, 2008

    Report

    Report Number
    2955842-2008-01227
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 30, 2008
    Report Date
    August 22, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    LFL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSERT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND THE CURVED BLADE IS INTACT, HOWEVER, THE CLAMP ARM IS MISSING FROM THE INSERT. ONE SIDE OF THE CLAMP ARM ATTACHMENT HINGE FEATURE (INNER AND OUTER TUBES) IS BENT, SUGGESTING THE CLAMP ARM WAS OVERLOADED. IT HAD BEEN CONCLUDED THAT THE "BLADE" REFERENCE BY THE CUSTOMER IS ACTUALLY THE CLAMP ARM OF THE HARMONIC CURVED SHEARS INSERT. THERE ARE NO COMPONENTS IN THE HARMONIC CURVED SHEARS INSTRUMENTS OR INSERTS THAT MEET THE DEFINITION OF "MEDICAL SHARPS". PER THE CUSTOMER REPORTED COMPLAINT, IT HAS BEEN CONCLUDED THAT THE "BLADE" REFERENCE BY THE CUSTOMER IS ACTUALLY THE CLAMP ARM OF THE HARMONIC CURVED SHEARS INSERT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S OVARIAN CYSTECTOMY PROCEDURE, WHEN THE SURGEON WAS TAKING OUT A SPECIMEN OF CYST USING THE TIP OF THE HARMONIC CURVED SHEARS INSTRUMENT, THE "BLADE" CAME OFF AND FELL INTO THE PT. THE "BLADE" WAS RETRIEVED AND THE PLANNED PROCEDURE WAS COMPLETED. INCIDENT LENGTHENED PROCEDURE ABOUT 2 HOURS. NO PT HARM ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC CURVED SHEARS INSERT ENDOSCOPIC ACCESSORY LFL INTUITIVE SURGICAL, INC. 400169-06

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ELECTROSURGICAL UNIT| DA VINCI S SURGICAL S SYSTEM| HARMONIC CURVED SHEARS INSTRUMENT