Catalog Number 8065797303 |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/16/2015 |
Event Type
malfunction
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Event Description
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A technician reported that the knob on an ophthalmic gas regulator valve would not open or close during surgery.An alternate procedure had to be performed.There was no impact to the patient.Additional information has been requested.
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Manufacturer Narrative
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No sample has been received by manufacturing for evaluation.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.Additional information has been requested.(b)(4).
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Search Alerts/Recalls
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