Model Number CLV-190 |
Device Problem
Optical Problem (3001)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/05/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned to olympus for evaluation.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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It was observed that during the device evaluation, the xenon light source exhibited brightness adjustment that did not work and could not make tissue distinguishable.There were no reports of patient involvement.
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Event Description
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It was reported, that during preparation for use, the xenon light source unit was not able to adjust brightness in auto or manual mode.There were no reports of patient harm.
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Manufacturer Narrative
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This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields: d8, h6.Corrected date: b5.The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was not confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over nine (9) years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.
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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.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over nine (9) years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's reportable malfunction was confirmed.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that unit is not able to adjust brightness in auto or manual mode occurred because the brightness control function did not work.Olympus will continue to monitor field performance for this device.
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Manufacturer Narrative
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The events can be detected/prevented in accordance with the following instructions for use: "never install a lamp that has not been approved by olympus.The use of a nonapproved lamp can cause damage to the light source and ancillary equipment, malfunction or a fire.".
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Search Alerts/Recalls
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