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السبت - جمادى الآخرة 8, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-19-10-25-1100
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Evis Exera III Duodenovideoscope, Evis Lucera Elite Duodenovideoscope and Duodenovideoscope
الأجهزة المتأثرة
Material Description (Model Number): 1- Evis Exera III Duodenovideoscope (TJF-Q190V) Material ID (UDI-DI): N5992960 (04953170407314) N5992950 (04953170416040) N5425051 (04953170436260) 2- Evis Lucera Elite Duodenovideoscope (TJF-Q290V) Material ID (UDI-DI): N5993260 (04953170405594) N5993250 (04953170436086) 3- Duodenovideoscope (TJF-Q170V) Material ID (UDI-DI): N6000360 (04953170408861) Serial Number(s): All.
الممثل المعتمد
Gulf Medical CO LTD
سبب المشكلة
Olympus’s ongoing assessment of TJF duodenoscope reprocessing to address positive cultures and infections has identified updates to the reprocessing materials, to minimize potential deviations in TJF duodenoscope reprocessing.
الإجراء التصحيحي
1. Carefully read the content of the attachment. 2. Access the Olympus education portal and complete the required training course, refer to the attachment. 3-Ensure all personnel are completely knowledgeable and thoroughly trained on the content of the attachment and the full extent of the TJF duodenoscope reprocessing steps as detailed in the reprocessing training materials. All applicable personnel should review these materials either via the downloaded documents or by accessing the education portal themselves. 4-Keep a copy of the attachment with your current Operation Manual. Olympus requests that you replace any existing copies of the Operation Manual with the updated Operation Manual and include a copy of the Visual Inspection Guide, obtained through the link in the attachment. 5-Olympus recommends that you receive on-site TJF duodenoscope reprocessing training at your facility. Manufacturer's Action: Instructions and Correction.
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