Datasets:

protocolsyncllc
/

field-safety-notices

+{"instruction":"Review the manufacturer's use of the electronic system for vigilance to ensure that the field safety notice for the Auto Suture Structural Balloon Trocar is entered and accessible to the public and competent authorities.","context":"The QMS document for the Auto Suture Structural Balloon Trocar states that field safety notices are distributed via email to key accounts and posted on the company website. It does not mention the entry of the field safety notice into the electronic system referred to in Article 92. The document also notes that the notice is not required to be made accessible to the general public, only to registered healthcare professionals.","response":"Field Safety Notice 05643/24 issued by BfArM on 2026-08-28 reported that healthcare professionals are instructed to inform all surgeons and clinicians who handle the preparation and/or placement of a Mesh or other devices that utilize the affected trocars for Medical instruments for use in humans - visceral surgery. This violates Article 92(1)(e) and Article 89(8) of Regulation (EU) 2017/745, which require manufacturers to enter field safety notices in the electronic system referred to in Article 92, through which that notice shall be accessible to the public. The technical failure is the reliance on private communication channels (email/website) instead of the mandated electronic system, which prevents the competent authorities and the public from accessing the safety information in a centralized and standardized manner."}
+{"instruction":"Review the design and construction of the Auto Suture Structural Balloon Trocar to ensure that the device is safe when used in combination with other devices, such as mesh products, and that restrictions on use are clearly indicated.","context":"The design specification for the Auto Suture Structural Balloon Trocar does not include any testing for compatibility with mesh products that are not from the same manufacturer. The instructions for use do not specify the compatible trocar sizes or the required hydration and folding techniques for the mesh. The document states that the device is intended for use with any standard mesh product, without acknowledging the risk of seal disengagement due to incompatible combinations.","response":"Field Safety Notice 05643/24 issued by BfArM on 2026-08-28 reported that trocar seal disengagement occurs when used with mesh products not in accordance with the mesh Instructions for Use for Medical instruments for use in humans - visceral surgery. This violates Annex I, Section 14.1 of Regulation (EU) 2017/745, which requires that if a device is intended for use in combination with other devices, the whole combination shall be safe and any restrictions on use shall be indicated on the label and/or in the instructions for use. The technical failure is the lack of design verification for combined use and the omission of critical usage restrictions in the IFU, which fails to minimize the risk of misconnection and seal disengagement."}
+{"instruction":"Assess the risk management of the Auto Suture Structural Balloon Trocar to ensure that the device is designed to remove or reduce risks associated with reasonably foreseeable external influences and interactions with other devices.","context":"The risk management file for the Auto Suture Structural Balloon Trocar does not include a risk assessment for the scenario where the seal disengages into the patient cavity. The document states that the risk of foreign body retention is considered low because the device is intended for use in controlled environments. There is no mitigation strategy for the risks of radiation exposure, allergic reaction, or tissue injury resulting from the seal disengagement.","response":"Field Safety Notice 05643/24 issued by BfArM on 2026-08-28 reported that seal disengagement may lead to potential risks including foreign body in the patient, radiation exposure, and tissue injury for Medical instruments for use in humans - visceral surgery. This violates Annex I, Section 14.2 of Regulation (EU) 2017/745, which requires devices to be designed and manufactured to remove or reduce as far as possible the risks associated with the use of the device when it comes into contact with materials or substances, and the risks of reciprocal interference with other devices. The logical failure is the exclusion of the seal disengagement scenario from the risk assessment, which fails to address the reasonably foreseeable risks of injury and harm to the patient resulting from the device's interaction with the mesh product."}
+{"instruction":"Review the Instructions for Use (IFU) for the Auto Suture Trocar to verify compliance with Annex I.14.1 regarding the safe use of device combinations and the indication of restrictions on use.","context":"The current IFU for the Auto Suture Trocar describes the device's standalone function but omits any specific warnings regarding its use with third-party mesh products. The document does not reference the mesh manufacturer's IFU or provide precautions for the interaction between the trocar and the mesh material. Consequently, users are not informed of the potential risks associated with improper combination use, leading to a lack of necessary safety guidance in the labeling.","response":"Field Safety Notice 05643/24 issued by BfArM on 2026-08-28 reported that insufficient warnings regarding the combination of the trocar with mesh products were present in the IFU for Medical instruments for use in humans - visceral surgery. This constitutes a violation of Regulation (EU) 2017/745 Annex I, Section 14.1, which mandates that restrictions on use applying to device combinations shall be indicated on the label and/or in the instructions for use. The technical failure lies in the omission of critical safety information regarding the interaction between the trocar and mesh, failing to minimize risks associated with the use of the device in combination with other products."}