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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-07-10-24-615
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
UroPass® Ureteral Access Sheath
الأجهزة المتأثرة
Model Number: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX ,61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX. Please refer to the attachment for more details.
الممثل المعتمد
Gulf Medical CO LTD
سبب المشكلة
Exposing the UroPass product to Ultraviolet (“UV”) Radiation can cause brittleness of the device dilator tip, which may lead to breakage.
الإجراء التصحيحي
-Inspect your inventory and determine if any of these devices with the model name specified above remain in inventory. Please check all areas of the facility/hospital. Add a copy of the attachment with your remaining inventory. You may continue to use the products in accordance with the instructions regarding UV exposure: Store individual UroPass Ureteral Access Sheath pouches away from ultraviolet (UV) light sources (including sunlight and artificial light). Exposure to UV light during storage periods may cause embrittlement of this device, increasing potential for breakage and patient injury. -If you want to return the UroPass device(s) in your inventory, please contact Olympus representative with regard to return and reimbursement procedure. Olympus will issue a credit to your facility upon return of your affected product.
المرفقات
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