Additional information: device evaluated by mfr.Investigation ¿ evaluation: the investigation included a visual inspection of the returned device, dimensional verification, functional testing, a review of complaint history, the device history record, drawings, instructions for use (ifu), quality control data, and the device specifications.One universa soft ureteral stent was received in an open package, label lot 8053517.The stent, positioner and wire guide were returned.The wire guide was returned inside the stent and positioner.The distal end of the positioner is tunneled inside the proximal end of the stent 4mm.A dimensional verification of the both the stent and positioner was performed.The tip of the returned positioner does not meet dimensional criteria.The proximal end of the stent was stretched out.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record showed there were no non-conformances identified during the manufacturing process that would cause or contribute to this reported failure mode.A review of complaint history for this product/lot number combination revealed this is the only complaint that has been received for this lot number.Based on the evidence presented by the sample and the physical analysis, this event has been attributed to a manufacturing event.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
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