BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE LAPAROSCOPIC SHEARS

    MDR report key: 6136072 · Received November 28, 2016

    Report

    Report Number
    MW5066417
    Event Type
    Injury
    Date Received
    November 28, 2016
    Date of Event
    November 23, 2016
    Report Date
    November 28, 2016
    Manufacturer
    ETHICON
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING A HARMONIC SCALPEL. IT STOPPED WORKING AND UPON INSPECTION OF THE SCALPEL, IT WAS NOTED TO BE MISSING THE BACK SIDE OF THE SCALPEL. AN X-RAY WAS PERFORMED AND IT WAS NOTED IN THE ABDOMINAL CAVITY. THE AREA WAS IRRIGATED. THE PT WAS X-RAYED AGAIN AND NO FOREIGN OBJECT NOTED. A SMALL PORTION OF THE BLADE WAS RECOVERED FROM THE SUCTION CANISTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780788 HARMONIC ACE LAPAROSCOPIC SHEARS HARMONIC ACE LAPAROSCOPIC SHEARS LFL ETHICON HARMONIC ACE LAPAROSCOPIC SHEAR N91D06

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention