Catalog Number 8065741076 |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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.(b)(4).
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Event Description
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A customer reported that the probe was out of order and it did not take correct measurements.Additional information has been requested.
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Manufacturer Narrative
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The company service representative examined the system and was able to replicate the reported event and identified the probe was the source of the issue.The company service representative requested a replacement probe.The pachymetry probe serial number (s/n) (b)(4) is manufactured by an outside supplier.Therefore, manufacturing information could not be obtained.The pachymetry probe was received and destroyed by technical services.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information was received indicating that there was no patient impact.
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Search Alerts/Recalls
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