Catalog Number 8065753048 |
Device Problem
Firing Problem (4011)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/22/2018 |
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 healthcare professional reported that the laser went to standby when firing during a retinal procedure.The system was rebooted to complete the procedure.There was no patient harm.
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Manufacturer Narrative
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The company service representative examined the system and could not replicate the reported event of a system message displayed.The fluidics module and ethernet cable were replaced as a prevention.The company service representative did replicate the reported issue of laser changing to standby mode.The nonconforming laser footswitch was replaced to resolve that issue.The system was then tested and met all product specifications.The system was manufactured on october 19, 2018.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to non-conforming laser footswitch.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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