Model Number UHI-4 |
Device Problem
Insufficient Flow or Under Infusion (2182)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/20/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device was returned to the olympus local service department.The olympus local service department checked the subject device and found that the reported phenomenon could not be duplicated.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
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Event Description
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Olympus medical systems corp.(omsc) was informed from the user that during the laparoscopic surgery with subject device, even if the set pressure of the subject device is set to 20/30/45 mmhg, the flow rate of the device does not exceed 7/8 l/min.The user completed the procedure by using the subject device.Other detailed information was not provided.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 provide additional information.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The olympus local service department checked the subject device and found that the reported phenomenon could not be duplicated.The exact cause of this event could not be conclusively determined.There were some items for which information could not be obtained.If significant additional information is received, this report will be supplemented.
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Search Alerts/Recalls
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