OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE; MEDIASTINOSCOPE
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Model Number WA53005A |
Device Problems
Poor Quality Image (1408); Optical Problem (3001)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/13/2022 |
Event Type
malfunction
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Event Description
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It was reported to olympus that a telescope fell on the ground during reprocessing.There was a mechanical failure that led to bad image and a cracked optic sleeve.There was no injury or health damage due to the reported event.
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Manufacturer Narrative
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Additional pma/510k numbers k923982/k950076.The device has not been returned to olympus.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.
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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.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 could not be determined as the device was not returned for evaluation.Although the device was not returned, based on the information provided from the customer, it is likely the bad image occurred to a damaged optical system.The damage to the optical system and black optic sleeve/eye piece funnel were caused by excessive force from the fall impact due to improper handling.Olympus will continue to monitor field performance for this device.
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