OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE; RIGID SCOPE
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Model Number WA53005A |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported to olympus that a telescope had partial eyepiece damage.It is unknown when the reported issue was found.There was no patient injury or adverse event reported to olympus.This medwatch is being submitted for the reportable malfunction found during evaluation.
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Manufacturer Narrative
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The device was returned to olympus for evaluation and repair.During the evaluation, the reported issue was confirmed, the eyepiece was found damaged.The image failure was also traced back to cover glass adhesion.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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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to e1 and g2.Correction: corrected e1 to translate to english.Checked "other" to add the country japan.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, it is likely the event occurred due to the user improperly handling and applying excessive force to the subject device.Olympus will continue to monitor field performance for this device.
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