A user facility has informed richard wolf gmbh an issue regarding a punch ø 5.4 mm wl 340 mm, part id: 892409020, lot # 4500355424.According to the received information, "when the product comes out of the bow, a piece remains in the nurse's hand.The tip comes off.No risk to the patient." additionally, this case was reported by the customer to the french national agency for the safety of medicines and health products (ansm).
|
During the inspection in the specialized department it was found that the head guide from the outer pipe is loose.The cause is due to welding not made deep enough.The punch ø 5.4 mm wl 340 mm, part id: 892409020 originates from the batch 4500355424 and was booked to the new goods warehouse on 02/may/2022.Apparently, no deviation was found during the incoming inspection.The delivery to the customer from this batch, took place on (b)(6), 2022.In general, the user is advised in the associated instructions for use ga-b251/ en/ eu/v1.0/ 2021-04 under chapter 9 that a visual and functional check must be carried out before and after each use.Possible damage of the above type can be easily detected by hospital staff if these instructions are followed.No comparable case, this type 892409020 is registered in the period under consideration.In our risk analysis b1-2 rev.05, manufacturing-related, handling-related and design-related hazards with regard to a functional impairment as well as risks due to an unusable product with the corresponding extent of damage and the assumed probability of occurrence were considered and assessed with an acceptable risk.
|