BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE INJECTOR

    MDR report key: 8681994 · Received June 10, 2019

    Report

    Report Number
    8010047-2019-02156
    Event Type
    Injury
    Date Received
    June 10, 2019
    Date of Event
    May 22, 2019
    Report Date
    August 2, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FBK
    UDI-DI
    04953170260070
    PMA / PMN Number
    K902736
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION, BECAUSE THE SUBJECT DEVICE WAS DISCARDED BY THE USER. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. BASED ON THE PAST SIMILAR CASES, IT WAS KNOWN THAT THE EVENT OCCURRED DUE TO COMPRESSIVE BUCKLING OF THE NEEDLE TUBE. THE COMPRESSIVE BUCKLING MIGHT OCCUR SINCE THE FRICTION RESISTANCE BETWEEN THE OUTER TUBE AND THE NEEDLE TUBE WAS HIGH WHEN THE NEEDLE TUBE WAS PUSHED OUT. THE FRICTION RESISTANCE MIGHT BE HIGH DUE TO THE FOLLOWING FACTORS. DURING INSPECTION, THE NEEDLE EXTENDED OR RETRACTED WHILE THE INSERTION PORTION WAS COILED. THE INSERTION PORTION WAS BENT TIGHTLY DURING USE. THE SLIDER WAS PUSHED ABRUPTLY. THE TUBE WAS BUCKLING. THE END OF THE ENDOSCOPE WAS ANGULATED. THE ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL AS FOLLOWS. STRAIGHTEN OUT THE INSTRUMENT BEFORE INSPECTING IT. THE INSTRUMENT CAN BE DAMAGED IF IT IS COILED WHILE THE HANDLE IS OPERATED. OPERATE THE SLIDER SLOWLY, OTHERWISE THE TUBE COULD BUCKLE. WHEN INSERTING THE INSTRUMENT INTO THE ENDOSCOPE, RETRACT THE NEEDLE INTO THE SHEATH, HOLD THE INSTRUMENT CLOSE TO THE BIOPSY VALVE, AND KEEP IT AS STRAIGHT AS POSSIBLE RELATIVE TO THE BIOPSY VALVE. OTHERWISE, THE INSTRUMENT COULD BE DAMAGED. INSERT THE INSTRUMENT SLOWLY. ABRUPT INSERTION COULD DAMAGE THE ENDOSCOPE AND/OR INSTRUMENT. STOP USING THE INSTRUMENT IF THE INSERTION PORTION BENDS EXCESSIVELY DURING USE. THIS COULD RESULT IN MALFUNCTION, SUCH AS FAILING TO EXTEND THE NEEDLE OR INJECT A FLUID.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION, BECAUSE THE SUBJECT DEVICE WAS DISCARDED BY THE USER. THE EXACT CAUSE HAS BEEN UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL OR SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME.

    Description of Event or Problem · 1

    DURING A STEROID INJECTION FOR SUBGLOTTIC STENOSIS, THE SUBJECT DEVICE WAS USED. THE USER COULD NOT PUSH A STEROID THROUGH THE NEEDLE TUBE REGARDLESS OF AMOUNT OF A PRESSURE. THE USER HAD TO INJECT A STEROID BY TRANS-TRACHEAL. THE SUBJECT DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476284 SINGLE USE INJECTOR INJECTOR AND SHEATHSET FBK OLYMPUS MEDICAL SYSTEMS CORP. NM-401L-0425 84K 04953170260070

    Patients

    Seq Age Sex Outcome Treatment
    1 Other