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Model Number CLV-180 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned for investigation.Upon evaluation of the device, the reported issue was not confirmed.However, a non-olympus lamp had insufficient thermal grease.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.
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Event Description
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The customer reported the evis exera ii xenon light source fan and scope distal end overheated.The event occurred during procedure and there was no patient harm or user injury reported due to the 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.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, and because the phenomenon was not duplicated during device evaluation, the root cause of the phenomenon could not be identified.There is a possibility of preventing the phenomena by following the descriptions in the instruction manual which states: "do not leave the examination lamp on when an endoscope is connected to the light source.The examination light reaches the maximum intensity and the endoscope¿s distal end becomes hot.In addition, smoke may also be produced if the debris attached to the distal end is heated." "·never install a lamp that has not been approved by olympus.The use of a non-approved lamp can cause damage to the light source and ancillary equipment, malfunction or fire." "·apply enough heat compound.If not enough heat compound is applied, the heat can cause lamp ignition failures." "keep the ventilation grills of the light source clear.The ventilation grills are located on the bottom and rear panels." olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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