OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE; MEDIASTINOSCOPE
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Model Number WA53005A |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/26/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned to olympus for evaluation and repair.The investigation is still in progress; therefore, the root cause of the reported defect cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.In general, the customer is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.Olympus will continue to monitor the field performance of this device.Additional pma/510(k): k923982/ k950076.
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Event Description
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It was reported to olympus that a telescope couldn¿t get connection piece off the light cable attachment.It is unknown when the reported issue occurred.There was no patient injury or adverse event reported to olympus.
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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 and to correct g2.During device inspection, the customer's complaint was not confirmed.Olympus found the light guide connector on the main body was detached and the image appeared blurry due to particles in optical system.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 root cause of the suggested event could not be concluded, although it can be presumed that the defect was caused due to excessive force by the customer.The customer's complaint and image issue are not reportable events.Per the legal manufacturer, there is no potential for these issues to cause or contribute to death or serious injury if the malfunctions were to recur.Olympus will continue to monitor field performance for this device.
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