Model Number TABLETOP-JAPAN |
Device Problem
Failure to Fire (2610)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/20/2022 |
Event Type
malfunction
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Event Description
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A healthcare professional reported that an ophthalmic console laser could not start during surgery.The surgery was completed with another device at outpatient clinic.The procedure details and patient impact were not reported.Additional information has been requested, but none received to date.
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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 confirmed and replicated the reported event.The core module was replaced to address the issue.The system was tested and found to meet product specifications.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 non-conformance based review of the batch/lot/serial number was performed and a potential contributing factor to the reported complaint was identified.An internal investigation was opened but was later determined to be irrelevant to this reported investigation.A review for complaints reported against this lot/batch/serial number was performed.No similar complaints were reported for the product lot/batch/serial under investigation the root cause of the reported event is attributed to nonconforming core 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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