BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIGLIDE

    MDR report key: 20771564 · Received November 25, 2024

    Report

    Report Number
    9681834-2024-00218
    Event Type
    Malfunction
    Date Received
    November 25, 2024
    Date of Event
    October 29, 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

    Narratives

    Additional Manufacturer Narrative · 0

    D4: LOT NUMBER: 231109 OR 231114 OR 231115 OR 231116. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. H4: MANUFACTURING DATE: 11/09/2023 OR 11/14/2023 OR 11/15/2023 OR 11/16/2023. THE ACTUAL SAMPLE WAS DISCARDED BY THE INVOLVED FACILITY. SINCE THE ACTUAL SAMPLE WAS NOT RETURNED, THE INVESTIGATION OF IT COULD NOT BE PERFORMED. NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. NO SIMILAR ISSUE HAS BEEN REPORTED FROM OTHER FACILITIES. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. IN ADDITION, NO ACTUAL SAMPLE WARE RETURNED AND THE INVESTIGATION OF IT COULD NOT BE PERFORMED; THEREFORE, IT WAS IMPOSSIBLE 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. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT PART OF THE GUIDE WIRE USED HAD BEEN STRIPPED, PREVENTING THE DEVICE FROM BEING FITTED DURING THE WORK. THE EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828910 VISIGLIDE ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY OCY TERUMO CORPORATION, ASHITAKA G-240-2545S 3YK 04953170282782

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown