BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC

    MDR report key: 2059311 · Received April 11, 2011

    Report

    Report Number
    MW5020247
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 11, 2011
    Manufacturer
    ETHICON-REPROCESSED BY ASCENT
    Product Code
    LFL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY THE SURGEON WAS DISSECTING THROUGH SOFT TISSUE WITH THE HARMONIC SCALPEL. ONE SIDE OF THE JAW (TIP OF INSTRUMENT) BROKE OFF. AFTER ATTEMPTING TO LOCATE THE SMALL BROKEN FRAGMENT THE SURGEON CONTINUED THE PROCEDURE. THE SURGEON NOTED THE PIECE WOULD NOT BE HARMFUL TO THE PT IF LEFT IN. THE PT WAS REFERRED BY THE SURGEON FOR ABDOMINAL X-RAY FOR CONFIRMATION OF THE MISSING FRAGMENT. THE SURGEON STATED HE WASN'T SURE IF IT WAS INSIDE THE PT OR NOT. APPROPRIATE CHAIN OF COMMAND FOLLOWED AND NOTIFIED ONCE EVENTS WERE DISCOVERED. CHARGE NURSE NOT AWARE OF SITUATION UNTIL THE PT HAD BEEN DISCHARGED HOME. USED 1 HR, 30 MINS. DIAGNOSIS OR REASON FOR USE: OBESITY SURGERY/REVISION OF LAP BAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC HARMONIC ACE SHEARS, 5.5 DIAMETER LFL ETHICON-REPROCESSED BY ASCENT ACE36E 1343426

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other