BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE ASPIRATION NEEDLE

    MDR report key: 10018251 · Received May 1, 2020

    Report

    Report Number
    8010047-2020-02443
    Event Type
    Malfunction
    Date Received
    May 1, 2020
    Date of Event
    April 18, 2020
    Report Date
    October 16, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FCG
    UDI-DI
    04953170389917
    PMA / PMN Number
    K050503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS DISCARDED AND WILL NOT BE RETURNED. DEVICE MANUFACTURE DATE IS NOT KNOWN. EVALUATION IS DONE BASED ON HISTORICAL RECORDS AND COMMUNICATION. ALSO, CORRECTION IS BEING MADE FOR INFORMATION AVAILABLE AT THE TIME OF INITIAL MDR SUBMISSION BUT NOT INCLUDED. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION. CORRECTION INFORMATION: PATIENT PRE-EXISTING CONDITIONS ARE ASTHMA, ARTHRITIS, GERD, HYPERTENSION. SUBJECT DEVICE WAS USED WITH CONCOMITANT DEVICE OLYMPUS EBUS BRONCHOSCOPE BFUC-180F-1111294. THE BRONCHOSCOPE DID NOT MALFUNCTION. THE PATIENT HAD SUBSEQUENT CHEST IMAGING ON (B)(6) 2020 REVEALED NO OTHER RESIDUAL FOREIGN BODY IN THE AIRWAY. THE PATIENT STATUS IS PATIENT IS DOING WELL. THE DEVICE WAS VISUALLY INSPECTED UPON REMOVAL FROM THE PACKAGING, BUT THE NEEDLE WAS NOT ADVANCED OUT OF THE SHEATH PRIOR TO USE DURING THE PROCEDURE. REPORTED ISSUE OF THE DEVICE IS THAT IT WAS FRACTURED FROM THE TIP IN THE PATIENT DURING PROCEDURE. THE NODE HAD A SUSPECTED FIBROTIC CAPSULE, AND AS SUCH WAS MORE DIFFICULT TO PENETRATE THAN USUAL. FROM THE PHOTOGRAPH SUBMITTED BY CUSTOMER, THE USER COMPLAINT IS CONFIRMED. THE DEVICE HISTORY RECORD REVIEW REVEALED THE LOT HAD PASSED ALL THE EVENT-RELATED INSPECTION ITEMS. ROOT CAUSE FOR THE ISSUE CANNOT BE DETERMINED SINCE THE PRODUCT IS DISCARDED. HOWEVER, PROBABLE CAUSE CAN BE THE FOLLOWING SEQUENCE: THE NEEDLE TUBE BUCKLED SIGNIFICANTLY DUE TO FORCE TO BEND IT, WHICH WAS POSSIBLY GENERATED BY MOVEMENTS OF THE PATIENT DURING THE PROCEDURE THE BUCKLED NEEDLE TUBE THEN RECEIVED FORCE TO STRAIGHTEN IT. THE BENDING AND STRAIGHTENING REDUCED THE STRENGTH OF THE NEEDLE TUBE UNTIL AND FINALLY BROKE IT OFF. THE INSTRUCTIONS FOR USE INCLUDES THE FOLLOWING STATEMENTS: WHEN INSERTING THE INSTRUMENT INTO THE ENDOSCOPE, THE DISTAL END OF THE NEEDLE TUBE MAY BE BENT. WHEN PIERCING THE TARGET, CONFIRM THE DISTAL END OF THE SHEATH AND NEEDLE TUBE IN THE ENDOSCOPIC FIELD OF VIEW AND/OR ULTRASOUND IMAGE WHILE CONSIDERING SUCH BENDING. OTHERWISE, PATIENT INJURY SUCH AS PERFORATION, BLEEDING, OR MUCOUS MEMBRANE DAMAGE MAY OCCUR. DO NOT TRY TO STRAIGHTEN A BENT OR DEFORMED NEEDLE WITH YOUR HANDS BECAUSE THE NEEDLE MAY BREAK. USE A SPARE NEEDLE INSTEAD. DO NOT PUSH THE NEEDLE SLIDER SUDDENLY. DOING SO MAY CAUSE SUDDEN NEEDLE PROTRUSION, RESULTING IN PERFORATION, BLEEDING, OR MUCOUS MEMBRANE DAMAGE. IT CAN ALSO DAMAGE THE INSTRUMENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, THE NEEDLE SHEATH/DEPLOYMENT APPARATUS AND PACKAGING WAS DISCARDED. A PHOTO OF THE NEEDLE TIP WAS PROVIDED FOR INVESTIGATION. THE CAUSE OF THE NEEDLE BREAKING COULD NOT BE DETERMINED. NO FURTHER INFORMATION WAS REPORTED. BASED ON SIMILAR REPORTED COMPLAINTS, THE MOST LIKELY CAUSE OF THE REPORTED PHENOMENON CAN BE ATTRIBUTED TO USER HANDLING OR TECHNIQUE. THE INSTRUCTION MANUAL STATES "IF YOU FEEL EXCESSIVE RESISTANCE WHILE OPERATING THE NEEDLE, DO NOT PUSH THE NEEDLE SLIDER FORCIBLY. DOING SO COULD CAUSE PATIENT INJURY, SUCH AS PERFORATION, BLEEDING, OR MUCOUS MEMBRANE DAMAGE. IT COULD ALSO DAMAGE THE INSTRUMENT AND/OR ENDOSCOPE".

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A BRONCHOSCOPIC BIOPSY PROCEDURE THE DISTAL END OF THE NEEDLE FRACTURED IN THE PATIENT'S AIRWAY. THE NODE HAD A SUSPECTED FIBROTIC CAPSULE, AND AS SUCH WAS MORE DIFFICULT TO PENETRATE THAN USUAL. THE INTENDED PROCEDURE WAS TERMINATED AFTER A FAILED FINAL BIOPSY PASS. THE NEEDLE FRACTURE WAS NOT RECOGNIZED UNTIL A FEW DAYS LATER WHEN THE PATIENT COUGHED OUT THE NEEDLE TIP. SUBSEQUENT CHEST IMAGING REVEALED NO OTHER RESIDUAL FOREIGN BODY IN THE AIRWAY. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480651 SINGLE USE ASPIRATION NEEDLE SINGLE USE ASPIRATION NEEDLE FCG OLYMPUS MEDICAL SYSTEMS CORP. NA-201SX-4021 98V 04953170389917

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR