Model Number FD-410LR |
Device Problem
Energy Output To Patient Tissue Incorrect (1209)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/13/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device referenced in this report has not yet been returned to olympus for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.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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During an endoscopic submucosal dissection, the subject device was used.When the user activated the subject device to stop bleeding, but the subject device did not work.The intended procedure was completed with another device.There was no patient injury reported.This is the report regarding failure of output.
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Manufacturer Narrative
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The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The subject device worked.There were no defects on the subject device.The manufacturing record was reviewed and found no irregularities.The exact cause of the reported event could not be conclusively determined because there were no defects on the subject device.However, based on the past similar cases, it was known that the event occurred due to any of the following possible causes.-the current density decreased due to increasing of contact area between the tissue and the subject device.-the subject device was not connected to the cord or the power supply correctly.The instruction manual of the device has already warned as follows; *pulling the tissue when applying the current.This could cause patient injury such as perforations and/or bleeding.When necessary, provide treatments to prevent perforations or bleeding from occurring after the procedure.Ensure that postoperative follow-ups are performed, and confirm that no abnormalities are found in the patient.
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Manufacturer Narrative
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This supplemental report is submitted to correct "device product code.".
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Search Alerts/Recalls
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