A user facility has informed richard wolf gmbh an issue regarding a cutting electrode bipo 24fr 12/30°, part id: 8622131, lot # 21003950.According to the received information, during procedure the loop has broken inside the bladder and the loop was burnt.
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The damage to the electrode indicates a high heat effect of the hf current between the electrode loop and the guide tube.Possible explanations for this heat effect is a short circuit between electrode loop and guide tube.Further activation results in high current densities and thus heat generation, which can lead to melting of metals.The present cutting electrodes bipo 24fr 12/30° part id: 8622131 originate from batch # 21003950.This batch was added to the neuwar-enlager on (b)(6) 2022 by our supplier, (b)(4).The supplier (b)(4) confirms in the chain of custody the inspection and compliance with the specification of this type and batch.The delivery to the customer took place on (b)(6) 2022.In summary, the information provided by the customer and the damage pattern suggest that improper handling has occurred (user error).To counteract this, the user is informed in the associated instructions for use about the checks to be carried out before and after each application.In addition, the user is advised not to use any to stop using any damaged products.The short-circuit could have been avoided by following these instructions in the instructions for use.The electrodes are subjected to a 100% electric breakdown test during production.A production-related defect can thus be largely excluded.Possible damage can be caused by reprocessing and ageing, and lack of visual inspection after reprocessing or before use can lead to the use of a defective product.Notes on this are listed in the instructions for use.Possible hazards due to thermal energy were considered in the risk assessment b2-3, rev.04 with the corresponding extent of damage and probability of occurrence.This assessment remains valid taking into account the new case.
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