Catalog Number 8065990941 |
Device Problem
Suction Problem (2170)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/19/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device history records (dhr) for the device were reviewed.The associated device was released based on acceptance criteria.Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A customer reported vacuum was lost during flap creation of the left eye.The patient interface was exchanged and the treatment was completed with no patient harm.
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Manufacturer Narrative
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Review of the logfile for the day of treatment shows the reported treatment could be identified in the logfile.According to the logfile the corresponding treatment was aborted after a warning message appeared.The user performed another vacuum check and passed the vacuum check.The treatment was restarted with a new patient interface and finished without any problems.Review of the logfiles for the treatment day prior the corresponding treatment day shows no relevant warning or error messages.No technical root cause was identified as the system was operating within specifications.The root cause could not be determined conclusively.The possible root cause could be docking technique or eye movement of the patient.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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