This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).Reported events: 2 events were reported for this quarter.Product return status: 1 device was received for evaluation.1 device was available for evaluation but has not yet been received.Evaluation status: 1 event was confirmed during testing.1 device was found to be affected by debris.1 device evaluation is in progress.Additional information: 2 devices were not labeled for single-use.2 devices were not reprocessed and reused.
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