One device was received for investigation.The reported issue was confirmed during visual inspection, which identified damage to the device tube.A review of manufacturing device history records for the reported lot number was conducted, and no discrepancies or anomalies were identified.Per the complaint description, the damage was not observed until its use in the patient.No damage was observed during the device pre-check.Based on the results of the inspection and the description of the event, the investigation determined the root cause could be due to improper use.No actions have been assigned at this time.
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