Catalog Number 8065990713 |
Device Problem
Unintended System Motion (1430)
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Patient Problem
Insufficient Information (4580)
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Event Date 06/16/2021 |
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.The manufacturer internal reference number is: (b)(4).
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Event Description
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A nurse reported a laser shutter issue during surgery.No patient harm was reported.A company representative assisted the doctor with resolving the reported issue.
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Manufacturer Narrative
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A review of the device history record (dhr) traceable to the reported serial number indicates that the product was processed and released according to the product¿s acceptance criteria.The root cause could not be determined conclusively.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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