Catalog Number 8065750597 |
Device Problem
Defective Device (2588)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/22/2020 |
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 customer reported during a laser procedure the laser did not produce a burn despite being fired.There was no system message displayed.The doctor had to increase the laser power to make the burn.Patient impact was not noted.
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Manufacturer Narrative
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The company service representative examined the system and replicated the reported event.The nonconforming laser core module was replaced to resolve the issue.The system was then tested and met all product specifications.Based on assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to a nonconforming laser core module.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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