Model Number TABLETOP |
Device Problem
Activation Problem (4042)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/20/2020 |
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 that during a surgery, laser of equipment was deactivating.No patient harm was reported.Additional information has been requested.
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Manufacturer Narrative
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The system was examined and the reported event was confirmed.The footswitch was replaced to resolve the issue.The system was tested and found to meet product specifications.The manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to nonconforming footswitch.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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