Model Number TABLETOP-JAPAN |
Device Problems
No Display/Image (1183); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/15/2021 |
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.The manufacturer internal reference number is: (b)(4).
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Event Description
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A physician reported that during surgery the console presented with blue blank on the screen panel and both top illumination ports were dark.The surgery was performed after the console was rebooted.There was no harm to the patient.
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Manufacturer Narrative
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The company service representative examined the system and was unable to confirm or replicate the reported event.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 have no problems; therefore, the root cause of the reported event cannot be determined conclusively.The 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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