Model Number TABLETOP |
Device Problems
Suction Problem (2170); Failure to Cut (2587); Noise, Audible (3273)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/20/2024 |
Event Type
malfunction
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Event Description
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A physician reported that during surgery, an ophthalmic console exhibited abnormal cutting speed and the probe was not working intermittently with several paks.Patient impact were not reported.Additional information received upon further follow up stating the planned surgery was a vitrectomy.The patient came into contact with the probe, the left eye being involved.There was no error message displayed and the console did not reach maximum vacuum and made a strange noise.
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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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Manufacturer Narrative
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The company representative was able to replicate the reported event.The pneumatic 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 the nonconforming pneumatic 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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