BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD-PARKER

    MDR report key: 4170344 · Received September 30, 2014

    Report

    Report Number
    1836161-2014-00057
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GES
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED: THE #11 BLADE CONTAINED INSIDE THE CASC SHOULDER ARTHROSCOPY PACK SNAPPED OFF IN PT. SPECIFICALLY IT CAME OFF WHOLE IN THE SHOULDER JOINT END WHILE THE SURGEON TRIED TO RETRIEVE IT, THE BLADE SNAPPED IN HALF INSIDE THE PT. NO PT INJURY REPORTED. BUT DUE TO THE NATURE OF THE ISSUE, CLINICAL DATA HAVE BEEN REQUESTED. ADDITIONAL CLINICAL DATA INFO RECEIVED FROM CUSTOMER END USER: BLADE REMOVED WITHOUT INJURY TO PT AND PT IS FINE. BLADE WAS FIRMLY SEATED AND NOT AWARE HOW MUCH TORQUE WAS APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606768 BARD-PARKER STAINLESS STEEL BLADES SIZE 11, STERILE GES ASPEN SURGICAL PRODUCTS, INC. 371211 0038475

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention