BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIGLIDE

    MDR report key: 20771553 · Received November 25, 2024

    Report

    Report Number
    9681834-2024-00207
    Event Type
    Malfunction
    Date Received
    November 25, 2024
    Date of Event
    August 16, 2024
    Report Date
    November 25, 2024
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    OCY
    UDI-DI
    04953170282782
    PMA / PMN Number
    K091417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D4: LOT NUMBER: 230805 OR 230828. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E1: REPORTER NAME: REQUESTED, UNKNOWN. E1: PHONE NUMBER: REQUESTED, UNKNOWN. E2: HEALTH PROFESSIONAL: REQUESTED, UNKNOWN. E3: OCCUPATION: REQUESTED, UNKNOWN. H4: MANUFACTURING DATE: 08/05/2023 OR 08/28/2023. THE ACTUAL SAMPLE WAS DISCARDED BY THE INVOLVED FACILITY. SINCE NO ACTUAL SAMPLE WAS RETURNED, INVESTIGATION OF IT COULD NOT BE PERFORMED. NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. NO OTHER SIMILAR REPORT WAS FOUND IN THE PAST. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. SINCE THE ACTUAL SAMPLE WAS NOT RETURNED AND INVESTIGATION OF IT COULD NOT BE CONFIRMED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GUIDE WIRE AND/OR ENDOTHERAPY ACCESSORY AND DETERMINE THE CAUSE BY FLUOROSCOPY OR ENDOSCOPE. CONTINUING TO MANIPULATE THE GUIDEWIRE COULD CAUSE PATIENT INJURY, SUCH AS PUNCTURES, HEMORRHAGES OR MUCOUS MEMBRANE DAMAGE. IT MAY ALSO DAMAGE THE ENDOSCOPE, INSTRUMENT AND/OR ENDOTHERAPY ACCESSORY." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE DEVICE RETURN DATE IN SECTION D9, UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. OUR INSPECTION OF THE RETURNED SAMPLE UPON RECEIPT FOUND THAT IT DOES NOT HAVE ANY ANOMALY. THIS COMPLAINT HAS TURNED TO BE "NOT REPORTABLE" BECAUSE THE DEVICE INVOLVED IN THIS COMPLAINT HAS BEEN VERIFIED TO BE THE NORMAL PRODUCT.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE GUIDE WIRE PEELED OFF EVEN THOUGH IT HAS NOT BEEN INTRODUCED INTO THE ENDOSCOPE OPERATING CHANNEL. ANOTHER GUIDE WIRE WAS TAKEN BEFORE STARTING THE PROCEDURE. THE EVENT OCCURRED PRE-TREATMENT AND THERE WAS NO PATIENT INVOLVED. THERE WAS NO PATIENT INJURY NOTIFIED BY THE CUSTOMER. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828899 VISIGLIDE ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY OCY TERUMO CORPORATION, ASHITAKA G-240-2545S 38K 04953170282782

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown