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Model Number CLV-190 |
Device Problem
Device Handling Problem (3265)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/01/2023 |
Event Type
malfunction
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Event Description
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The customer reported to olympus, that the light source produced a lot of smoke, there was a loud bang and a spark when using the evis exera iii xenon light source for an oesophago-gastro-duodenoscopy (oed) diagnostic procedure.The procedure was successfully completed in a different examination room with a similar device/processor.There was a report of delay due to changing to another examination room.There was no harm to the patient or user associated with this event.
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Manufacturer Narrative
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The device was returned to olympus for evaluation and the customer's allegation was not confirmed.The light source was checked and tested.After starting up the device by switching the supply power on, neither abnormal sound nor smoke were generated as reported by the customer.There was no visible damage related to either of the reported events.Additional evaluation findings were as follows: there was dust/dirt accumulation found inside the block which most certainly had a negative influence on the device¿s performance and probably resulting in the phenomena initially reported, there were several serious impacts noticed inside the block, the socket for the light-guide cable and the front panel were both broken, and the turret was bent.The defects found were attributed to mistakes/careless handling.The investigation is ongoing, and 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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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to udi.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the phenomenon "delayed procedure associated with laboratory changes (no other events suspicious of harm)" , phenomenon " device to smoke", and phenomenon "device to spark" occurred due to dust was found inside device, which negatively affected device's performance and likely caused client-reported events.However, the root cause of the phenomenon's could not be identified.Additionally, the phenomenon "extended procedure time" likely occurred due to delay in equipment replacement.However, the root cause of the extended procedure time could not be specified.The event can be prevented by following the instructions for use which state: [important information ¿ please read before use] "avoid using the light source in a dusty environment.This may damage the light source." olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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