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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Manufacturer Narrative
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The light source was returned to the service center for evaluation.The customers complaint of ¿no power¿ was confirmed.The lamp failed to turn on due to a faulty thermal fuse.In addition, the scope was losing pressure due to a worn out air joint unit, connector socket and mount.An investigation is ongoing to obtain additional information regarding this event.
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Event Description
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The user facility reported that during reprocessing, the light source did not exhibit power.There was no patient involvement.
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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 due to the device manufacture occurring over 15 years ago.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The case is not due to design.Based on the results of the investigation, it was confirmed that the power could not be turned on because the thermal fuse was broken.The cause of the faulty thermal fuse is likely due to the device condition/use because it has been over 15 years since the device was manufactured.Olympus will continue to monitor the field performance of this device.
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Search Alerts/Recalls
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