|
Model Number CYF-VHA |
Device Problem
Material Twisted/Bent (2981)
|
Patient Problem
Hemorrhage/Bleeding (1888)
|
Event Date 09/27/2022 |
Event Type
Injury
|
Event Description
|
The customer reported to olympus malfunctions with three (3) scopes and the malfunctions may have caused patient bleeding during the procedure.The distal tip is dislocated and the image is out of alignment by approximately 90 degrees.A request for additional information is in progress.This event includes 4 reports: (b)(6): patient 1, cyf-vha, (b)(4).(b)(6): patient 2, cyf-vha, (b)(4).(b)(6): patient 3, cyf-vha, (b)(4).(b)(6): patient 4, cyf-vha, (b)(4).This report is 1 of 4.
|
|
Manufacturer Narrative
|
The suspect device has been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
|
|
Manufacturer Narrative
|
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the reported issue could not be reproduced.Additional findings noted during the inspection are as follows: 1.The distal tip - dislocated.2.Insertion tube condition ¿ delamination evident.3.Up/down angle ¿ not to specification.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, since there was a scratch noted on the bent section at the detached part of the device, it is likely that an external force was applied which caused the detachment of the bent section.However, since the condition of the bending section cover is unknown, it is not possible to determine the factors that caused the reported event.Olympus will continue to monitor field performance for this device.
|
|
Manufacturer Narrative
|
This supplemental report is being submitted to provide additional information based on the legal manufacturer¿s re-investigation.Based on the results of the re-investigation, since the tip connecting part corresponded to the thin-walled resin part of the device, it was rotated off from the curvature by applying external force.As a result, the image may have been shifted with respect to the 90 degrees curvature direction, likely causing the bleeding.However, the root cause of the reported event could not be identified.Also, correction made to h6 code (investigation conclusion).Olympus will continue to monitor field performance for this device.
|
|
Search Alerts/Recalls
|
|
|