Model Number SPL-T |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Device inspection of the returned transducer found that the suction outlet was damaged.No additional failures were noted.The device is non repairable.The investigation is ongoing; therefore, the root cause of the reported failure cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
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Event Description
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It was reported that during an asset return inspection the device was found with damaged suction outlet.There was no patient involvement on this event reported.No user injury 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 investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Based on device evaluation results, damage to the device's suction outlet was most likely due to user mishandling.The device ifu advises :this product is a precision device; handle it with care.Avoid rough or violent handling, which may cause equipment damage.Olympus will continue to monitor complaints for this device.
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Search Alerts/Recalls
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