BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE GUIDEWIRE

    MDR report key: 21583125 · Received March 12, 2025

    Report

    Report Number
    9681834-2025-00032
    Event Type
    Injury
    Date Received
    March 12, 2025
    Date of Event
    February 7, 2025
    Report Date
    March 12, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    OCY
    PMA / PMN Number
    K091417
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4: LOT NUMBER: 46K (ESTIMATED TO BE 240605, 240606, 240613); D4: (B)(4); D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED; D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED; E2: HEALTHCARE PROFESSIONAL: UNKNOWN; E3: OCCUPATION: UNKNOWN. THE ACTUAL SAMPLE WAS NOT RETURNED. SINCE THE ACTUAL SAMPLE WAS NOT RETURNED, INVESTIGATION OF IT COULD NOT BE PERFORMED. HISTORY INVESTIGATION OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE PRODUCT INSPECTION RECORD. CAUSE OF OCCURRENCE/CONCLUSION: BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. SINCE THE INVESTIGATION OF ACTUAL SAMPLE COULD NOT BE PERFORMED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. INSTRUCTIONS FOR USE (IFU): "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." (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 THE GUIDEWIRE (GW) TIP PART PEELS OFF. REPORTEDLY, THIS ISSUE INVOLVES THE FOLLOWING OLYMPUS PRODUCT G-260-2545A. ACCORDING TO THE AVAILABLE INFORMATION, THIS ISSUE DID NOT CAUSE OR CONTRIBUTE TO A POSITIVE TEST CULTURE, (SUSPECTED) INFECTION, DEATH; DID NOT OCCUR DURING A PROCEDURE. POSSIBLE RESIDUALS IN THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1560936 SINGLE USE GUIDEWIRE ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY OCY TERUMO CORPORATION, ASHITAKA OL-XA25455M 46K

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other