Corrected data: the udi number and the product reference was incorrect and has been corrected in this report.According to sophysa in-house process, the probe (b)(4)/e0137 has been analyzed by the quality control department.The traceability documents do not show any performance abnormality or any causality : the product history and batch records were reviewed and documentation indicated the product met release criteria.A visual inspection performed on the probe shows that the catheter is clean (the catheter has not been implanted) and that connections pins are not in the axis of the electronics card.This deviation explains the appearance of this event, involving connection difficulties noted by the user.However, this deviation does not make the connection impossible but makes the manipulation a bit difficult.In addition, as indicated in the product's instructions for use, an available replacement kit is required before implantation.Finally, the catheter has not been implanted and thus, the event did not contribute to a serious injury.
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