Model Number UHI-4 |
Device Problems
Gas/Air Leak (2946); Pressure Problem (3012)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 01/26/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Since the subject device has been not returned to omsc for the evaluation, the exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
|
|
Event Description
|
Olympus medical systems corp.(omsc) was informed that it was found the co2 gas leakage from the subject device when the subject device was returned by the user to the spare parts center of olympus (b)(4) as one of the loaner devices.The user (borrower) reported that the co2 gas leakage had found before the user set up the subject device at the user facility and so the subject device had been returned to olympus (b)(4).At the incoming inspection, olympus (b)(4) checked the subject device and found the co2 gas leakage from the pressure reducing valve, the failure of the electropneumatic proportional valve, the failure of the manifold valve, and the aging co2 gas tubes.There was no report of patient injury associated with this event.
|
|
Manufacturer Narrative
|
This supplemental report is being submitted to provide additional information.Since the subject device was not returned to olympus medical systems corp.(omsc), it could not be investigated.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.However, based on the report of olympus china, omsc surmised there was the possibility this phenomenon was attributed to the manifold unit failure of the subject device due to the aging deterioration by passing more than 6 years since manufacturing the subject device.If additional information becomes available, this report will be supplemented.
|
|
Search Alerts/Recalls
|
|