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الثلاثاء - ربيع الآخر 22, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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تواصل معنا
EN
SA-09-02-25-779
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
AESCULAP® Haemostatic forceps
الأجهزة المتأثرة
Please refer to the attachment.
الممثل المعتمد
Gulf Medical CO LTD
سبب المشكلة
According to market feedback, the Haemostatic forceps have been used according to indications which are currently not covered by the design (e.g. larger blood vessels or fixation of medical materials) leading to customer complaint cases related to the breakage of the device(s) during use caused by the failure mode "breakage of the box lock".
الإجراء التصحيحي
As the devices are limited by their design of the jaw length, the use is limited to the occlusion of minor blood vessels by design and size. The devices cannot be used for the occlusion of large blood vessels. The intended purpose and intended use section of the Instructions for Use (IFU) has been updated to further emphasise this limitation to include: "Haemostatic Clamps are used for clamping of tissue and small vessels." The user is requested to promptly implement the new product-specific Instructions for Use (IFU), which is in the attachment, and to ensure the compliant use of the device(s) at patients. Additionally, the user must immediately implement guidelines for verifying the safety and performance of the device(s) within the context of lifecycle monitoring during the reprocessing routine, refer to the attachment for more information. Manufacturer action: Instructions.
المرفقات
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