Model Number GIF-H180J |
Device Problem
Device Reprocessing Problem (1091)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The device was reprocessed before it was returned for evaluation.The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported, the gastrointestinal videoscope plastic distal end cover had foreign material in jet tube exit.Image errors/streaks were noted by the user.It was not indicated if the issue occurred during patient examination.There were no reports of patient harm or impact associated with this event.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.Correction to g3 of the initial medwatch.The aware date should be 08apr2024.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over (11) years since the subject device was manufactured.The legal manufacturer presumed that foreign material may not have been removed due to imperfection of proper reprocessing caused by leakage from electrical connector guide pin.Based on the results of the investigation, it could not be determined what the foreign material was.Although, olympus confirmed foreign material adhered/clogged in probe cover.The suggested event may be detected and prevented by handling device in accordance with the following instructions for use.Instructions for use states detection methods in evis exera ii gif type 180 series operation manual, chapter 3 preparation and inspection.Instructions for use states prevention measures in evis exera ii gif type 180 series reprocessing manual, chapter 5 reprocessing the endoscope (and related reprocessing accessories).Olympus will continue to monitor field performance for this device.
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Event Description
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It was observed during the device inspection, that the gastrointestinal videoscope exhibited foreign material on probe cover.There were no reports of patient involvement.
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Search Alerts/Recalls
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