Model Number TJF-Q180V |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device in this report has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
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Event Description
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Olympus medical systems corp.(omsc) was informed from the user that during the preparation for use, the forceps elevator of the subject device could not be moved.The procedure was canceled.The field service engineer of olympus (b)(4) confirmed the reported issue at the facility.Olympus (b)(4) checked the subject device and found that there was the gap on the adhesive of the distal end.There was no report of patient injury associated with the event.
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Manufacturer Narrative
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This supplemental report is being submitted to report the withdrawal of mfr report #8010047-2020-09364 and correct the initial report submitted on nov 24, 2020.As a result of the investigation, olympus medical systems corp.(omsc) concluded that this complaint was not reportable event because it was found that the reported phenomenon had not occurred resulting from the investigation.
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Search Alerts/Recalls
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