Based on the information available to us, we were able to confirm the event, and determined that the y-port was damaged.The device history record (dhr) for this product is established based on the serial number of the device however no serial number was provided therefore the dhr could not be reviewed.The suppliers reviewed their manufacturing processes, testings, inspections, and established controls; no issues were found.The tests and inspections can 100% detect y-port damage during the assembly process.Based on the available information it was determined that the y-port had been damaged during use by external force as there is no risks to cause the y-port damage during the manufacturing process.No actions are required at this time.All information received will be used for further tracking and trending purposes.
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