Device Problems
Break (1069); Device Reprocessing Problem (1091)
Patient Problem
No Patient Involvement (2645)
Event Type
Malfunction
Manufacturer Narrative
The device was received by olympus evaluation.
The user facility report was confirmed and found leaking at a rubber glue and damage on the scope.
Additional information provided by the reporter on (b)(6) 2020 confirmed that the sterile processing team at the facility did not put the valve back on the scope during reprocessing which may have led to the defect of the scope.
The device has been serviced and returned to the user facility.
Olympus will continue to monitor complaints for this device.
Event Description
The user facility reported that the distal end of the scope is broken.
Additional information provided by the reporter on august, 7 2020 confirmed that the sterile processing team at the facility did not put the valve back on the scope during reprocessing which may have led to the defect of the scope.
The reporter indicated that corrective actions have been taken on site with training to ensure this doesn't happen in the future.
No additional information was provided.