Model Number CLV-190 |
Device Problems
Obstruction of Flow (2423); Misassembly by Users (3133)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.The evaluation uncovered air leak coming from the scope socket, the flow rate was out of specification and the lamp had 400 or more hours.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 to olympus during preparation, the air was not working properly on the evis exera iii xenon light source.There were no reports of patient harm associated with this event.
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Manufacturer Narrative
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Updated fields: b5, d8, e3 this report is being supplemented to provide additional information based on thee additional information provided by the customer.Olympus will continue to monitor the field performance of this device.
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Event Description
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During a colonoscopy procedure.The tech and doctor noticed that the air was not working properly prior to the procedure (was weak).Another scope was tested and the same occurred.After testing the air for a few minutes, the air began to work more effectively.A delay was reported, but it is unknown how long.The device was inspected and only issue that was noticed was the air was not working sufficiently.The procedure completed using the same device.
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Event Description
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In addition, the olympus service center found the heatsink assembly was not assembled properly and washers were missing.This report was submitted for the malfunction found during evaluation (improper lamp installation).
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the approved final investigation and to correct section b5/h6.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, the lamp was not properly assembled in the heatsink.The washer was not attached when the lamp was replaced.However, the definitive root cause of the installation issue could not be determined.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿ washers are attached to bolts.Retain all three of them carefully because they will be used again to clamp the new examination lamp.¿ olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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