BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRA-I CS RETRACTOR BODY

    MDR report key: 3577238 · Received November 14, 2013

    Report

    Report Number
    2242352-2013-01559
    Event Type
    Malfunction
    Date Received
    November 14, 2013
    Date of Event
    October 21, 2013
    Report Date
    October 21, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GAD
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETED. SINCE THIS IS AN OEM SUPPLIED DEVICE, A LOT HISTORY REVIEW IS NOT APPLICABLE. (B)(4).

    Description of Event or Problem · 1

    DURING AN INSPECTION PRIOR TO PROVIDING IT TO A HOSPITAL IN (B)(6), IT WAS OBSERVED THAT A SCREW ON THE MIRA-I CS RETRACTOR BODY WAS LOOSE AND NOT ATTACHED TO THE BLADE WHERE THE SCREW ABLES THE PIVOT MECHANISM. IT WAS REPORTED THAT THE MIRA-I CS RETRACTOR BODY WAS USED IN (B)(6), DECONTAMINATED, AND TRANSPORTED TO (B)(6) FOR DISTRIBUTION. THE DEVICE WAS NEVER RECEIVED BY THE HOSPITAL. IT WAS STATED THAT IT MAY HAVE OCCURRED DURING THE CLEANING PROCESS IN (B)(6). THE DEVICE IN QUESTION IS INTENDED TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591349 IRA-I CS RETRACTOR BODY CLAMPLESS BEATING HEART GAD MAQUET CARDIOVASCULAR, LLC MS-0104 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA