BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    'ENDOSCRUB SHEATH STZ 4MM 30DGR

    MDR report key: 2070585 · Received April 27, 2011

    Report

    Report Number
    1045254-2011-00028
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EOB
    PMA / PMN Number
    K902683/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH 3500A FORM WAS RECEIVED FROM THE REPORTER. ANY MISSING OR INCOMPLETE DATA ON THIS FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED OR RELEASED BY THE REPORTER. MULTIPLE ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION WERE MADE, AND THE RECORDS OF THESE ATTEMPTS ARE DOCUMENTED IN THE COMPLAINT FILE. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. THIS DEVICE WAS OUT OF SPECIFICATIONS IN AN AS RECEIVED CONDITION.

    Description of Event or Problem · 1

    DESCRIPTION OF THE ORIGINAL COMPLAINT: THE ENDOSCRUB SHEATH WAS FLAKING PLASTIC PIECE DURING A PROCEDURE. RELEVANT EVENTS AND INFORMATION OBTAINED FOR THE REPORTED CASE: AT THE CONCLUSION OF A FESS CASE THE DOCTOR NOTED SEVERAL BLACK FLAKES IN THE PATIENT'S NOSE. IT TOOK THE DOCTOR APPROXIMATELY 10 MINUTES TO RINSE THE PARTICULATE OUT OF THE PATIENT'S NOSE. NO FURTHER INTERVENTION WAS REQUIRED. THE PATIENT'S CONDITION WAS REPORTED AS BEING FINE. ANALYSIS OF THE RETURNED SHEATH WAS PERFORMED. TWO BLACK PLASTIC FLAKES MEASURING APPROXIMATELY 10.7MM IN LENGTH WERE RETURNED WITH THE REPORTED PRODUCT. AN ENDOSCOPE WAS INSERTED INTO THE SHEATH AND AN INTERNAL INSPECTION OF THE SHEATH'S METAL SHAFT AND PLASTIC HUB WAS PERFORMED. NO DAMAGE, DEFECT OR OTHER ABNORMALITY WAS FOUND IN THE PLASTIC HUB OR METAL SHAFT. THE FLAKES AND SHEATH WERE FURTHER ANALYZED BY FOURIER TRANSFORM INFRARED SPECTROSCOPY, AND A COMPARISON OF SHEATH AND FLAKE MATERIAL DETERMINED THAT THE FLAKES WERE OF A DIFFERENT COMPOSITION THAN THE ENDOSCRUB SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 'ENDOSCRUB SHEATH STZ 4MM 30DGR EOB MEDTRONIC XOMED INC. 1850200 H7741768

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention