OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 45°, HD, QUICK LOCK, AUTOCLAVABLE; AUTOCLAVABLE RIGID TELESCOPE
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Model Number WA53010A |
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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Manufacturer Narrative
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The subject device was returned to the olympus repair center for evaluation and the customer¿s reported problem was confirmed/reproduced as the light guide post was damaged.Additionally, the objective coverglass at the distal end of the scope was found broken.The inspection also observed a dent on the rigid outer tube and the image is blurry or distorted.The investigation is still in progress; 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.Additional 501(k): k923982/ k950076.
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Event Description
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The customer high definition, quick lock autoclavable rigid telescope was returned to the olympus repair center for a reported ¿the light guide connector part cannot be removed¿.The customer reported event was found at an unspecified event.During the olympus inspection, a broken objective coverglass at the distal end of the scope was found.No death or injury and no impact to patient or other has been reported to olympus.No further details regarding the event have been obtained or provided.This report is being submitted to capture the broken objective lens at the distal end.
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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 h8.Please see updates to h6, h8, and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 12 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely the connector part couldn¿t be removed due to user error, improper handling and application of excessive force.The final root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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