تسجيل الدخول
تسجيل جديد
الاثنين - رجب 2, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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أسئلة شائعة
تواصل معنا
EN
SA-17-12-25-1186
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
da Vinci Single Port System Access Port Kits
الأجهزة المتأثرة
Part Number (Product Name; Affected Lot Number; Unique Device Identifier): 430073 (ACCESS PORT KIT,WOUND RETRACTOR,2.7-4CM,SP1098,BOX OF 6; K11250807; 00886874119549) 430075 (ACCESS PORT KIT,WOUND RETRACTOR,2.7-7CM,SP1098,BOX OF 6; K10250701; 00886874119556)
الممثل المعتمد
Gulf Medical CO LTD
سبب المشكلة
It has been identified by Intuitive that a subset of tray tubs may develop cracks. Because the tray tub contributes to the sterile barrier, a crack may cause a sterility breach, resulting in the product no longer being sterile at the time of use.
الإجراء التصحيحي
Customers are instructed to: - Follow the warning provided in the SP Access Port Kit User Manual Addendum (555435-04). An excerpt of this warning is provided in Appendix A of the attachment. -Identify affected inventory. -Quarantine affected units. -Cease use immediately. -Return affected products to Intuitive representative. Manufacturer Action: Instructions and removal.
المرفقات
عودة للقائمة
