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 08/03/2018 |
Event Type
malfunction
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Manufacturer Narrative
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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.Manufacturing record reviewed.No abnormalities that could have contributed to this event were found.(b)(4).
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Event Description
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An optometrist reported suction was lost 50 percent through the procedure.The patient did not move and there was no harm.Event occurred after the laser was fired.The procedure was completed.
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Manufacturer Narrative
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A logfile review of the day of the treatment showed the three system test for vacuum, energy and ablation were executed by the user without any problems.The reported treatment could be identified in the logfile.The treatment was aborted after the warning message.The user restarted the treatment and performed the treatment successfully on that day.No technical root cause was detectable.The root cause is user handling.The root cause is user handling.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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