Catalog Number 8065752200 |
Device Problem
Air Leak (1008)
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Patient Problem
No Information (3190)
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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.(b)(4).
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Event Description
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A customer reported "a lot bubbles" during surgery, which "hindered the surgeon's vision." the procedure was completed with the same product.There was no patient harm.Upon follow up it was informed that there is no product sample available for evaluation.
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Manufacturer Narrative
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The lot specific to this event is not known; therefore, lot history and device history record review is not possible.A sample has not been returned for this complaint; therefore, visual inspection and functional testing could not be performed.The affiliate informed that a sample is not available.The root cause of the customer's complaint could not be established as a sample was not returned for investigation.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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