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Model Number CLK-4 |
Device Problem
Component Missing (2306)
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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 device was returned to olympus for evaluation and customer allegation was confirmed.The device evaluation revealed the unit was impacted with front panel broken in pieces, bottom chassis, top cover and serial number plate at the rear was deformed, and the rear panel and two metal plates inside had a minor deformity.Additionally, the evaluation revealed the main lamp with chip off and spare lamp missing.The investigation is ongoing and follow up with the user facility is currently being performed.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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The customer reported to olympus that the front panel of the halogen light source was broke/damaged during an unspecified procedure.There was no patient harm or impact reported.The device was returned to an olympus service center for evaluation.During inspection and testing, service confirmed the front panel was broken off, and found that the spare lamp was missing.This mdr is being submitted to capture the reportable malfunctions found during the device evaluation.
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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.Please see updates to h4, h6 and h10.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, the root cause of the spare lamp missing was unable to be identified.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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