Model Number UCR |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Perforation (2001)
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Event Type
Injury
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Manufacturer Narrative
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The subject devices were not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.However, as an evaluation result of four ucrs (each serial numbers are (b)(4)) by an olympus local service engineer, there was no defect found.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
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Event Description
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It was reported that two intestinal perforations occurred during an unspecified procedure with the ucr.The user assumed that these perforations were caused by an excessive pressure release of the ucr.The user owns four ucrs (each serial numbers are (b)(4)).However, the user did not provide any information, about the condition of the patient or which ucr was used during the procedure, due to patient data protection.No further information was provided.This is the second report of two intestinal perforations.
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Manufacturer Narrative
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This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.The device history record was reviewed and found no irregularities.According to an evaluation result of four ucrs (each serial numbers are (b)(6)) by an olympus local service engineer, there was no defect found.Based on the evaluation result so far, omsc surmised the reported event was attributed to another device, not subject device.
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Search Alerts/Recalls
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