Model Number CV-180 |
Device Problems
Corroded (1131); Poor Quality Image (1408); Naturally Worn (2988)
|
Patient Problem
No Patient Involvement (2645)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The device referenced in this report has returned to olympus for evaluation.Preliminary findings are reported.The definitive cause of the customer's experience cannot be determined at this time.The investigation is ongoing.Physical evaluation of the complaint device reveals: the user's report is confirmed.The image flickers in and out due to worn out video connector pins.The front panel is worn out with minor corrosion on the chassis.The software version is 4.0.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
|
|
Event Description
|
It is reported while preparing an evis exera ii video system for use, it was found to have an intermittent signal causing the image to flicker in and out.There was no patient contact/impact related to this occurrence.
|
|
Manufacturer Narrative
|
Additional information was received from the customer on 26-feb-2021.The event occurred at the beginning of a diagnostic cystoscopy with a flexible cystoscope.There was no delay in the procedure and no anesthesia used.The same device was used to complete the procedure.There was no known patient information known as the image flickered in and out on multiple patients.No other devices were replaced during the procedure.The processor was sent in for repair.Unknown if there was any impact to the patient or procedure, if the connections or settings were checked and found to be correct, and if the electrical contacts/optical connecting parts were cleaned and if any residue was found.It was also unknown if there were any error codes or any abnormalities noted in the connecting cables.The device was inspected prior to use and no abnormalities were noted.
|
|
Manufacturer Narrative
|
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device that would have caused or contributed to the reported issue.The device met all specifications at the time of shipment.Based on the results of the legal manufacturer's investigation, it is likely that the signal was interrupted due to wear of the video connector part/pins due to long-term use, causing the image to flicker.
|
|
Search Alerts/Recalls
|