BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMAL ACCESS ATTACHMENT

    MDR report key: 3060771 · Received April 5, 2013

    Report

    Report Number
    1045834-2013-01316
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Report Date
    April 6, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    ERL
    PMA / PMN Number
    K965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. RELIABILITY ENGINEERING EVALUATED THE DEVICE, AND THE REPORTED PROBLEM WAS CONFIRMED. THE DEVICE WAS TESTED AND EXCEEDED TEMPERATURE SPECIFICATIONS. THE ATTACHMENT WAS OBSERVED TO HAVE WORN AND DRIED OUT BEARINGS. THIS CONDITION IS LIKELY DUE TO NORMAL USE AND WEAR OVER TIME, BUT MAY HAVE BEEN EXACERBATED BY INEFFECTIVE CLEANING AND MAINTENANCE OF THE DEVICE. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE (B)(6) STATING THAT THE DEVICE WAS "HEATING." THE DEVICE WAS NOT BEING USED DURING A PROCEDURE. THE DATE OF THE EVENT IS UNK. NO PT OR USER INJURIES REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139682 MINIMAL ACCESS ATTACHMENT ERL THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1