Model Number UHI-4 |
Device Problem
Audible Prompt/Feedback Problem (4020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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The customer reported to olympus, when the high insufflation unit is turned on, a beep sound occurs and operation is not possible.During inspection of the returned device, a faulty board was found.There was no report of patient harm associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
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Manufacturer Narrative
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The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.The failure was caused by a faulty board.The visual inspection of the returned device found no abnormality in appearance.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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Event Description
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The customer reported to olympus, when the high insufflation unit is turned on, a beep sound occurs and operation is not possible.There was no report of patient harm associated with this event.
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Manufacturer Narrative
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This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation, device history record (dhr) review and applicable corrections.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.Based on the results of the investigation, the faulty board was determined to be the cause of the failure.However, it is unknown what caused the board to fail.Olympus will continue to monitor the field performance of this device.
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Search Alerts/Recalls
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