Catalog Number 8065797303 |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/18/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A sample is available that has not yet 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.(b)(4).
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Event Description
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A health professional reported that an ophthalmic gas regulator valve would not allow gas to dispense during an in-service.There was no procedure or patient involvement associated with this report thus, no patient impact.
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Search Alerts/Recalls
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