BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE ASPIRATION NEEDLE

    MDR report key: 3063191 · Received February 27, 2013

    Report

    Report Number
    8010047-2013-00050
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) AT PRESENT FOR EVAL. HOWEVER, THERE WERE NO ABNORMALITIES RELATED TO THE PHENOMENON IN THE DEVICE. BASED ON THE PREVIOUS INVESTIGATION RESULTS OF SIMILAR COMPLAINTS, THE REPORTED PHENOMENON WOULD OCCUR IF THE USER OPERATES THE NEEDLE FORCIBLY WHILE THE DISTAL END OF THE DEVICE IS IN THE SCOPE CHANNEL. 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." "IF YOU FEEL EXCESSIVE RESISTANCE WHILE OPERATING THE NEEDLE, DO NOT PUSH THE NEEDLE SLIDER FORCIBLY. DOING SO COULD CAUSE PT INJURY, SUCH AS PERFORATION, BLEEDING, OR MUCOUS MEMBRANE DAMAGE. IT COULD ALSO DAMAGE THE INSTRUMENT AND/OR ENDOSCOPE."

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENT REPORT IS BEING SUBMITTED TO PROVIDE THE DEVICE EVALUATION REPORT. THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THAT THE DISTAL END OF THE TUBE SHEATH WAS KINKED AND THERE WAS A PERFORATION WHICH SEEMED TO BE PIERCED BY NEEDLE ON THE OUTSIDE OF THE KINK PORTION. AS THE CHECKING OF THE MANUFACTURING RECORD OF THE SAME LOT, NOTHING ABNORMAL WAS DETECTED. ACCORDING TO THE INVESTIGATION, OMSC ASSUMES THAT THE USER PRESSED THE DISTAL END OF THE TUBE SHEATH AGAINST TISSUE AND ATTEMPTED TO PROJECT OUT THE NEEDLE AND THESE HANDLING LED TO THIS EVENT. THE DEVICE INSTRUCTION MANUAL WARNS USERS THAT "DO NOT FORCE THE DISTAL END OF THE INSERTION PORTION AGAINST BODY CAVITY TISSUE." 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 ULTRASONIC GUIDED BRONCHOSCOPIC NEEDLE ASPIRATION BIOPSY (TBNA), THE SUBJECT DEVICE WAS LODGED WITHIN THE CHANNEL OF THE BRONCHOSCOPE. AFTER THE DEVICE AND THE BRONCHOSCOPE WERE WITHDRAWN FROM THE PT, THE FACILITY REPORTEDLY FOUND THAT THE NEEDLE OF THE DEVICE STUCK OUT FROM THE TUBE SHEATH OF THE DEVICE IN THE AREA 4MM FROM THE DISTAL END. THE FACILITY REPORTEDLY WITHDRAWN THE DEVICE FROM THE BRONCHOSCOPE AND COMPLETE THE PROCEDURE USING ANOTHER ASPIRATION NEEDLE. THERE WAS NO PT HARM REPORTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) PERFORMED A MDR RETROSPECTIVE REVIEW AND OMSC FOUND THAT THIS SUPPLEMENTAL REPORT IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84550 SINGLE USE ASPIRATION NEEDLE ASPIRATION NEEDLE FOR BRONCHOSCOPE FCG OLYMPUS MEDICAL SYSTEMS CORPORATION NA-201SX-4022 2YK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK