Model Number SPL-S |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/12/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The evaluation of the event is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.Three attempts were performed to obtain additional information, but no response was received from the customer.
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Event Description
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It was reported the subject device had a damaged connector.The issue was found during preparation for use.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.The device was returned to olympus for inspection and the reported failure was confirmed.The transducer could not plug in due to broken transducer receptacle.A review of the device history record found no deviations that could have caused or contributed to the reported issue.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: cause traced to component failure, which is expected or random component failure without any design or manufacturing issue.Olympus will continue to monitor field performance for this device.
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Event Description
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It was reported the subject device had a damaged connector.The issue was found during preparation for use.There were no reports of patient harm.
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Search Alerts/Recalls
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