Catalog Number 8065753041 |
Device Problem
Operating System Becomes Nonfunctional (2996)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/01/2023 |
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 that in an ophthalmic system laser function switched off when in use.The procedure details and patient impact was not reported.
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Manufacturer Narrative
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The company representative was able to confirm nor replicate the reported event.The footswitch and tray arm were both replaced to address the issues.The system was tested and found to meet product specifications.A non-conformance based review of the serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product serial under investigation.The root cause of the reported ¿laser turning off¿ is attributed to the nonconforming footswitch.The root cause of the reported ¿broken gas strut on the tray arm¿ is attributed to the nonconforming component in the tray arm.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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