OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE; MEDIASTINOSCOPE
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Model Number WA53005A |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/06/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device was 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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Event Description
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It was reported to olympus that presence or absence of recurrence of cracks in the joints in a telescope.The issue was found during repair of the device.There was no injury or health damage due to the reported event.
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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 device evaluation.The device was returned to olympus for inspection, and the customer's complaint was confirmed.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.It is likely the reported event occurred due to the use of excessive force from improper handling.In addition, the following non-reportable malfunction was found during the device evaluation: peeling of the gold plating on the outer tube.Olympus will continue to monitor field performance for this device.
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Event Description
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The reported malfunction was a crack in the eye piece tube.The intended procedure was for treatment and there was no delay.The scope is used about three times per week and the customer performs pre-use inspections.
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