OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE; HD AUTOCLAVABLE TELESCOPE
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Model Number WA53005A |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The subject device was returned to the olympus repair center.The customer reported issue was confirmed, the lens is moving under the objective window at the distal end.No other abnormalities were found.The investigation is ongoing; therefore, the cause of the customer event cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.In general, the end user is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.
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Event Description
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Olympus (oci) was informed that the customer high-definition, quick lock, autoclavable telescope¿s ¿lens moving¿.The customer reported problem was found during reprocessing.No death, injury or harm was reported.
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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.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 cause of the reported issue is most likely due to excessive use.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu) which recommends always having a replacement device available during an application.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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