Model Number TABLETOP-JAPAN |
Device Problems
Failure to Cut (2587); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2023 |
Event Type
malfunction
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Event Description
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A physician reported that during the surgery, the vitreous cutter made an unusual noise and the cutter actuation sometimes stopped.The problem was recovered by replacing the probe and noise remained the same.Type of surgery and patient details were not reported.No patient harm was not reported.
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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 unable to confirm nor replicate the reported event.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 non-conformance based review of the serial number was performed and a potential contributing factor to the reported complaint was identified and reviewed as a part of this investigation.The non-conformance was opened but was later determined to be irrelevant to this investigation.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product serial under investigation.The system was found to meet specifications.Therefore, the root cause of the reported event is inconclusive.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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