Model Number UHI-4 |
Device Problem
No Device Output (1435)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/28/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect device was returned to the olympus service center for evaluation.Upon inspection and testing of the device, the screen blacked out and an alarm was generated, confirming the customer¿s reported alarm and operating failure.The issue was found to be due to a failure of the pressure sensor circuit/printed-circuit board.Additionally, the inspection found the insufflation flow rate was low.The investigation is ongoing; therefore, a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
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Event Description
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The user facility reported that during preparation for a laparoscopic surgery (before patient was anesthetized), the device generated an alarm, and the user could not operate the system.Another similar device was used to complete the procedure.There was a procedure delay of less than fifteen minutes.There was no patient injury reported due to the event.
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Manufacturer Narrative
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This report is being supplemented to provide additional information, based on the approved final investigation.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, the definitive root cause of the faulty pressure sensor circuit/printed-circuit board could not be determined.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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