This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).
Reported events: ten events were reported for this quarter.
Product return status: nine devices were received for evaluation.
One devices were available for evaluation but have not yet been received.
Evaluation status: four events were confirmed during testing -four devices were found to be affected by detached or missing pieces.
Five device evaluations are in progress.
Product disposition: these devices are not repairable and were not returned to the user facility.
Additional information: there were no remedial actions taken on this device.
This device is not labeled for single-use.
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