BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPECT PULMONARY OLYMPUS 25GA

    MDR report key: 6124785 · Received November 23, 2016

    Report

    Report Number
    3005099803-2016-03610
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Report Date
    November 3, 2016
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    EOQ
    PMA / PMN Number
    K151315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE WORKING LENGTH OF THE NEEDLE AND SHEATH WAS BENT AT THE DISTAL END OF THE HANDLE. ADDITIONALLY, THE DISTAL TIP OF THE NEEDLE WAS BENT. THE COMPLAINT THAT THE NEEDLE DISTAL TIP BENT WAS CONFIRMED. THE INVESTIGATION CONCLUDED THAT THIS COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS DESIGN AND MANUFACTURE SPECIFICATIONS BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE OF THE DEVICE WAS LIMITED. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION FOR THE REPORTED FAILURE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO DEVIATIONS WERE FOUND.

    Additional Manufacturer Narrative · 1

    UDI = (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY OLYMPUS NEEDLE WAS USED IN PROCEDURE. EXACT PROCEDURE DATE UNKNOWN. ACCORDING TO THE COMPLAINANT, THE NEEDLE TIP WAS BENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY OLYMPUS NEEDLE WAS USED IN PROCEDURE. EXACT PROCEDURE DATE UNKNOWN. ACCORDING TO THE COMPLAINANT, THE NEEDLE TIP WAS BENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774407 EXPECT PULMONARY OLYMPUS 25GA ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE EOQ BOSTON SCIENTIFIC - SPENCER M00558250 19651893

    Patients

    Seq Age Sex Outcome Treatment
    1