SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA III XENON LIGHT SOURCE; ENDOSCOPIC LIGHT SOURCE UNIT, LINE-POWERED
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Model Number CLV-190 |
Device Problems
No Display/Image (1183); Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/29/2022 |
Event Type
malfunction
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Manufacturer Narrative
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In speaking with olympus technical assistance center (tac), the customer was advised to power off everything, remove the scope, clean the contact points on the scope, let it dry, reconnect the scope and turn power back on, and observe the result.The customer noted that the scopes worked correctly when they were plugged into a different tower.The customer swapped the maj-1933 and maj-1941 cables which resolved the issue.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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Event Description
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The customer reported to olympus technical assistance center (tac), that the evis exera iii xenon light source had a loss of image after it was plugged in.The site noted that the scope was repaired and a b30 scope communication error occurred 2 days later.There were no reports of patient harm associated with this event.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 10 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, and the inability to evaluate the subject device and duplicate the event, a definitive root cause of the lost image and b30 error could not be identified.However, it¿s likely the cause is related to a faulty maj-1933 (digital light source cable) and maj-1941 (light source cable).Olympus will continue to monitor field performance for this device.
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