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Model Number 744000 |
Device Problems
Output below Specifications (3004); Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/02/2022 |
Event Type
malfunction
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Event Description
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User facility reported the device saline output is weak.The issue found during an unknown event.No harm was reported.No patient injury, no user injury reported due to the event.
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Manufacturer Narrative
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The subject device was not returned for evaluation.Communication with the customer (biomed) , technical assistance center (tac) support engineer was informed that the facility nurse stated that the saline output is weak and that another gyrus device was attached and worked fine.Customer stated not aware of any errors that occurred, however, when tac advised to retrieved the device error logs, it was determined that the only error that was present was error 400-26, indicated a user error related to accessories.The unit passed the self test and rebooted fine, customer informed tac that the case can be close.In addition, the customer stated it will relay, will inform facility nurse what error means and that it passed the self test, that the unit is in working order.Tac noted customer needed no further assistance.Supplemental report(s) will be submitted should any relevant new information is available.Investigation is ongoing.This report will be supplemented accordingly following investigation.
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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, as well as corrections to d5, e2, e3, and h8.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 7 years since the subject device was manufactured.The customer confirmed that the issue was resolved after the subject device was rebooted.Based on the results of the investigation, the root cause of the event (weak saline output) was unable to be identified, as the device was not returned for evaluation.Olympus will continue to monitor field performance for this device.
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Event Description
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Additional information was received which confirmed the reported event (saline output is weak) occurred during a procedure.
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Search Alerts/Recalls
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