BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLASSVAN PLUS

    MDR report key: 4908115 · Received July 9, 2015

    Report

    Report Number
    1058382-2015-00001
    Event Type
    Injury
    Date Received
    July 9, 2015
    Date of Event
    June 1, 2015
    Report Date
    October 25, 2016
    Manufacturer
    M/S NIRAJ INDUSTRIES PVT LTD.
    Product Code
    GES
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    WHILE AFFIXING THE BLADE CARTRIDGE ON THE SCALPEL HANDLE, THE TECHNICIAN WAS CUT BY THE BLADE AND REQUIRED TWO (2) STITCHES. THE EVENT OCCURRED PRIOR TO PATIENT TREATMENT. THE TECHNICIAN REPORTEDLY PLACED HER FINGER OVER THE SHEATH OPENING WHILE INSTALLING THE DEVICE AND SUBSEQUENTLY APPLIED ENOUGH FORCE WHEN PRESSING DOWN TO LOCK THE BLADE IN PLACE ON THE HANDLE TO ACTIVATE THE SHEATH EXPOSING THE BLADE TIP. THIS METHOD OF INSTALLATION WAS IN DIRECT CONTRADICTION TO THE INSTRUCTIONS FOR USE, AS WELL AS THE TRAINING THE TECHNICIAN RECEIVED PRIOR TO USING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446106 GLASSVAN PLUS BLADE CARTRIDGE GES M/S NIRAJ INDUSTRIES PVT LTD. 0249X UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other