Model Number TABLETOP-JAPAN |
Device Problems
Failure to Cut (2587); Noise, Audible (3273)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/06/2023 |
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 physician reported that an ophthalmic console vitreous (vit) cutter drive malfunction occurred and the noise was abnormal during surgery.The drive of the probe temporarily deteriorated and the drive rotation slowed or stopped.The surgery was performed and completed on the same day by using another console without any problems.The type of procedure and patient impact were not reported.
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Manufacturer Narrative
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The company representative was able to replicate the reported event.The pneumatics module was replaced to address the issue.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 event is attributed to nonconforming pneumatics module.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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