Catalog Number 8065751763 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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No sample has been received by manufacturing for evaluation.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.(b)(4).
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Event Description
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A health professional reported that an ophthalmic operating system locked up.Procedure details information is unknown.There was no report of any patient impact.Additional information has been requested.
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Manufacturer Narrative
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The company service representative examined the system and was not able to confirm or replicate the reported event.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The system was found to meet specifications therefore, the root cause of the reported event cannot be determined conclusively.Data will continue to be monitored for evidence of adverse trending with further action taken, as appropriate.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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