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الثلاثاء - رجب 24, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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أسئلة شائعة
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EN
SA-11-01-26-1207
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Triangle Tip Knife J – Single Use Electrosurgical Knives
الأجهزة المتأثرة
Material (Model, Product Name, UDI-DI): N2119630 (KD-640L, Single Use Electrosurgical, 04953170208423) N5412530 (KD-645L, Single Use Electrosurgical, 04953170407857) Lot Number(s): See the attachment.
الممثل المعتمد
Gulf Medical CO LTD
سبب المشكلة
The affected devices may breaking off during use, due to deterioration of the cutting knife, caused by overheating and burning, can contribute to tip breakage during use.
الإجراء التصحيحي
1. Carefully read the content of the attachment. 2. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of the attachment, including the instruction for intermittent output activation and applicable Warnings and Cautions. 3. Keep a copy of the attachment with the Instructions for Use for any affected devices remaining in your inventory. Manufacturer's action: Instructions.
المرفقات
عودة للقائمة
