Model Number CLH-SC |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/21/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned to olympus for evaluation and the repair center confirmed the customer's complaint.Based on the results of the investigation, it is likely the event was caused by the user hitting another device on the power switch or it was caused by deterioration over time due to the repeated use of the device.
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Event Description
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The customer contacted olympus to report the power switch was broken and the device had exposed terminals.The device malfunction was found during maintenance and there was no patient involvement.
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Manufacturer Narrative
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This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.Correction to g3 of the initial medwatch.The aware date should be 21-jul-2020.Olympus will continue to monitor the field performance of this device.
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Search Alerts/Recalls
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