BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE ASPIRATION NEEDLE

    MDR report key: 3060736 · Received March 29, 2013

    Report

    Report Number
    8010047-2013-00059
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 28, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) SINCE THE FACILITY DISCARDED THE SUBJECT DEVICE. HOWEVER, THERE WERE NO ABNORMALITIES RELATED TO THE PHENOMENON IN THE MANUFACTURING RECORD OF THE SUBJECT DEVICE. BASED ON THE PREVIOUS INVESTIGATION RESULTS OF SIMILAR COMPLAINTS, THE REPORTED PHENOMENON WOULD OCCUR IF THE USER OPERATES THE NEEDLE DURING THE INSERTION WHILE THE NEEDLE IS NOT LOCKED BY THE NEEDLE ADJUSTER. THE DEVICE INSTRUCTION MANUAL WARNS USERS THAT "CONFIRM THAT THE NEEDLE SLIDER IS PULLED UNTIL IT CLICKS AND IS LOCKED BY THE NEEDLE ADJUSTER BEFORE INSERT THE INSTRUMENT INTO THE ENDOSCOPE. OTHERWISE, THE NEEDLE'S DISTAL END MAY PIERCE THE ENDOSCOPE'S INSTRUMENT CHANNEL OR THE NEEDLE'S DISTAL END MAY EXTEND FROM THE DISTAL END OF THE ENDOSCOPE ABRUPTLY. "DO NO EXTEND THE SHEATH FROM THE DISTAL END OF THE ENDOSCOPE WITHOUT CONFIRMING IT IN THE ENDOSCOPIC FIELD OF VIEW. OTHERWISE, IT COULD CAUSE PATIENT INJURY, SUCH AS PERFORATION, PNEUMOTHORAX, BLEEDING, OR MEMBRANE DAMAGE. IT COULD ALSO DAMAGE THE ENDOSCOPE AND/ OR INSTRUMENT." THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING AN ENDOBRONCHIAL ULTRASOUND-GUIDED TRANS - BRONCHIAL NEEDLE ASPIRATION (TBNA), THE USER FOUND THAT THE NEEDLE OF THE SUBJECT DEVICE HAD ALREADY PROTRUDED FROM THE DISTAL END OF THE SUBJECT DEVICE AND THE NEEDLE COULD NOT BE RETRACTED WHEN ITS DISTAL END EXTENDED FROM THE CHANNEL OF THE ENDOSCOPE. IT WAS REPORTED THAT THE USER IMMEDIATELY WITHDRAW THE SUBJECT DEVICE FROM THE SCOPE. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129740 SINGLE USE ASPIRATION NEEDLE ASPIRATION NEEDLE FOR BRONSCOPE GAA OLYMPUS MEDICAL SYSTEMS CORPORATION NA-201SX-4021 28K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK