Model Number UHI-4 |
Device Problems
Display or Visual Feedback Problem (1184); No Device Output (1435)
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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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An olympus employee reported on behalf of the customer, the high flow insufflation unit segment was having a light-emitting diode (led) problem.There was a seven (7) segment lighting failure.It was always switching.There was no report of user or patient harm associated with this event.
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Manufacturer Narrative
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The subject device was returned to olympus for evaluation.During inspection and testing, the allegation was confirmed.It was determined that there was an led failure.Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information becomes available.
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Event Description
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Additional information was provided regarding this event.The failure occurred before procedure.It had been reported that the device was always ¿switching.¿ it was clarified that the customer was referring to the same event, not additional occurrences.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, information provided by the customer (refer to b5 and applicable corrections (h8).A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that a faulty light-emitting diode (led) caused the failure, however, its unknown what caused the led to fail.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.
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Search Alerts/Recalls
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