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Model Number CLK-4 |
Device Problems
Failure to Power Up (1476); Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/24/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The customer suspected device was returned for investigation.The olympus service center confirmed the reported event during inspection and testing.Upon evaluation of the returned device the following defects were found, unit powered on but failed to light up halogen lamp due to faulty thermal fuse, air pressure fluctuated due to worn out air joint unit, connector socket and mount, spare lamp missing and air pressure low due to faulty air pump unit.The faulty parts were replaced, and the device was returned to the user facility.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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Event Description
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A user facility reported to olympus that the halogen light source was over heating and could not turn on.Upon inspection and testing of the customer returned device, the light source had blown thermal fuse which resulted in light failing to light up and missing spare lamp.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.There was no report of patient harm or user injury associated with this event.
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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.Since the device is more than 15 years old, the device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely due to the faulty thermal fuse, the halogen lamp did not light up when the power was turned on occurred because the thermal fuse became defective due to overheating.However, a definitive root cause could not be determined.The spare lamp being missing was confirmed but a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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