Model Number UHI-4 |
Device Problems
Defective Alarm (1014); No Display/Image (1183)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The device was returned to olympus for evaluation.A full technical evaluation was completed in accordance with the olympus' specification.The insufflator was tested: after starting up it went into alarm mode (alarm sound occurred) and no indicators were lighted on front panel.It was identified that all these phenomena were related to a failure of the cr board.Additionally, it was also noticed that the alarm generated during testing indicated a decrease in the remaining amount of co2 in the cylinder.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
|
|
Event Description
|
It was reported to olympus that during abdominal surgery procedure, the high flow insufflation unit alarm sounded with no image displayed on the screen.The device was reset, and the procedure was completed with the same device.There was no harm or user injury reported due to the event.
|
|
Manufacturer Narrative
|
The device was returned to olympus for evaluation.A full technical evaluation was completed in accordance with the olympus' specification.The insufflator was tested: after starting up it went into alarm mode (alarm sound occurred) and no indicators were lighted on front panel.It was identified that all these phenomena were related to a failure of the cr board.Additionally, it was also noticed that the alarm generated during testing indicated a decrease in the remaining amount of co2 in the cylinder.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
|
|
Event Description
|
It was reported to olympus that during abdominal surgery procedure, the high flow insufflation unit alarm sounded with no image displayed on the screen.The device was reset, and the procedure was completed with the same device.There was no harm or user injury reported due to the event.
|
|
Manufacturer Narrative
|
This report is being supplemented to provide additional information based on the legal manufacturer's 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: - there is a possibility that the display went off due to the failure of the circuit board, but the cause of the failure of the circuit board could not be determined.- an alarm may have gone off because the remaining amount of co2 in the cylinder decreased, but it was not possible to determine the cause of the decrease in the amount of co2 remaining in the cylinder.Olympus will continue to monitor field performance for this device.
|
|
Search Alerts/Recalls
|