BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART XS MEDIAN RETRACTOR ONLY

    MDR report key: 3810473 · Received April 15, 2014

    Report

    Report Number
    2916714-2014-00237
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    February 7, 2014
    Report Date
    April 15, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    GAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MANUFACTURING SITE EVALUATION: THERE IS VISIBLE MATERIAL FRETTING IN THE AREA OF THE DRIVE. THE MANUFACTURING AND QUALITY DOCUMENTATION HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THERE ARE NO INDICATIONS FOR A MATERIAL OR MANUFACTURING DEFECT. THE EXCESSIVELY STRONG MATERIAL WEAR IS CAUSED BY INSUFFICIENT OILING AND CLEANING. NO FURTHER ACTIONS REQUIRED.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). RETRACTOR WAS NOT MOVABLE INTRAOPERATIVE AND HAD TO BE REMOVED RIGID FROM THE PATIENT. NO INTERFERENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230766 HEART XS MEDIAN RETRACTOR ONLY CARDIAC RETRACTOR FOR MIN INVASIVE GAD AESCULAP AG & CO. KG FC137R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other