BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE ASPIRATION NEEDLE

    MDR report key: 16395110 · Received February 17, 2023

    Report

    Report Number
    3005975494-2023-00022
    Event Type
    Malfunction
    Date Received
    February 17, 2023
    Date of Event
    April 12, 2022
    Report Date
    May 23, 2023
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    KTI
    UDI-DI
    00821925043060
    PMA / PMN Number
    K163469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION (H6/H10) AND TO UPDATE H4. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE FOLLOWING INFORMATION IS STATED IN THE INSTRUCTIONS FOR USE (IFU): "ALWAYS HAVE A SPARE INSTRUMENT AVAILABLE IN CASE THE PRIMARY INSTRUMENT MALFUNCTIONS." (PAGE 7). IN ADDITION, WARNINGS GIVEN ON PAGE 16 " 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." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE INITIAL MEDWATCH INCORRECTLY REPORTED THE SITE REGISTRATION NUMBER. THE SITE REGISTRATION NUMBER IS 3011050570.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. THE CAUSE OF THE REPORTED ISSUE IS UNKNOWN AT THIS TIME. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Description of Event or Problem · 0

    AS REPORTED, DURING ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY (EBUS) PORTION OF PROCEDURE (DIAGNOSTIC) AFTER COLLECTING SAMPLE, THE NEEDLE WAS STUCK INSIDE THE SHEATH. STAFF COULD NOT REMOVE NEEDLE FROM THE SHEATH TO OBTAIN ANY FURTHER SAMPLES. NEW NEEDLE WAS OPENED. PER THE CUSTOMER, DEVICE WAS EXAMINED. NO HOLES NOTED ON OUTSIDE OF PLASTIC SHEATH THAT COULD BE IDENTIFIED. NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED. THE REPORTED ISSUE OCCURRED ON THE SAME MODEL (NA-U403SX-4019) WITH DIFFERENT LOT NUMBERS ON DIFFERENT EVENT DATE. THIS EVENT INCLUDES FOUR (4) REPORTS TO CAPTURE THE REPORTED ISSUE OCCURRED ON THE SAME MODEL WITH DIFFERENT LOT NUMBERS AND EVENT DATE. REPORT WITH PATIENT IDENTIFIER (B)(6) (LOT KR151147) - EVENT DATE OF (B)(6) 2022. REPORT WITH PATIENT IDENTIFIER (B)(6) (UNKNOWN LOT) -DISPOSED BY THE CUSTOMER- NOT SAVED- EVENT DATE OF (B)(6) 2022. REPORT WITH PATIENT IDENTIFIER (B)(6) (LOT KR232986) - EVENT DATE OF (B)(6) 2022. REPORT WITH PATIENT IDENTIFIER (B)(6) (LOT KR232986) -UNKNOWN EVENT DATE. THIS REPORT IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) (LOT KR151147) - EVENT DATE OF (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119826 SINGLE USE ASPIRATION NEEDLE VIZISHOT 2 FLEX KTI GYRUS ACMI, INC. NA-U403SX-4019 KR151147 00821925043060

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown