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Model Number A22002A |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/05/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The evaluation of the event is ongoing, the item was not returned.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported, that the hysteroresectoscope had a broken part with twenty percent lost light output.The issue was found during a demonstration for a therapeutic cutting of polyp fibroids.There were no reports of patient harm.
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Manufacturer Narrative
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This supplemental report is being submitted to provide the results of 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.It has been over 16 years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's reportable malfunction, a broken part and 20% loss of light output, was confirmed.Based on the results of the legal manufacturer's investigation, it¿s likely that the cause was related to excessive force applied by the customer.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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