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تسجيل جديد
الثلاثاء - ربيع الآخر 22, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-09-02-25-780
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Forceps/Irrigation Plug (Isolated Type)
الأجهزة المتأثرة
Material ID: N6149350. Model/Catalog Number: MAJ-891. Lot Number(s): All. UDI: 04953170063114. Please refer to attachment for the model names of the Olympus endoscopes with which the MAJ-891 may be used as an accessory.
الممثل المعتمد
Gulf Medical CO LTD
سبب المشكلة
A potential risk of patient infection due to inadvertent retention of biomaterial when the reprocessing procedure for the MAJ-891 is not performed as instructed, such as not disconnecting the MAJ-891 from the endoscope and disassembling it before reprocessing.
الإجراء التصحيحي
1. Carefully read the content of the attachment. 2. Use alternative devices to the MAJ-891 according to the compatibility table in the attachment. 3. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of the attachment. Specifically, please ensure that all reprocessing personnel are completely knowledgeable and thoroughly trained on the MAJ-891 reprocessing instructions. 4. Olympus will contact you to schedule a mutually beneficial time for an Olympus Field Representative to visit your facility and review the contents of the attachment and the MAJ-891 reprocessing instructions. Refer to the “Training and Resources” section in the attachment for additional resources. Manufacturer action: Instructions.
المرفقات
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