BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    874.4250

    MDR report key: 2746921 · Received September 12, 2012

    Report

    Report Number
    1045834-2012-00017
    Event Type
    Malfunction
    Date Received
    September 12, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 10, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    ERL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT. A FOLLOW-UP WILL BE PROVIDED ONCE THE DEVICE HAS BEEN RETURNED AND EVALUATED.

    Description of Event or Problem · 1

    HOSE RUPTURE: DURING PATIENT SETUP AND PREP FOR AN ANTERIOR CERVICAL DISCECTOMY, THE XMAX AIR HOSE RUPTURED. THE RESULT WAS A LOUD POPPING SOUND. FOR CONCERNS OF STERILITY THE XMAX SYSTEM WAS REMOVED AND RE-PROCESSED. THERE WAS A DELAY TO SURGERY DUE TO RE-PROCESSING THE EQUIPMENT, PREPPING AND DRAPING THE PATIENT. THE PATIENT WAS NOT INJURED DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 874.4250 PNEUMATIC SURGICAL DRILLING SYSTEM ERL THE ANSPACH EFFORT, INC. XMAX MOTOR

    Patients

    Seq Age Sex Outcome Treatment
    1