Model Number CLK-4 |
Device Problem
Failure to Power Up (1476)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported to olympus that their halogen light source motor does not initiate when powered on for an unspecified procedure.There was no reported patient death, harm, or injuries related to this event.
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Manufacturer Narrative
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Additional information has been requested and not yet provided.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The dhr was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation and the inability to evaluate the device, a definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.
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Search Alerts/Recalls
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