Model Number CLV-S40PRO |
Device Problem
Failure to Power Up (1476)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/06/2022 |
Event Type
malfunction
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Manufacturer Narrative
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In addition, service found the output connector (light guide connection) was loose.The chassis and the top cover were corroded.The high intensity mode was not working.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.
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Event Description
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The customer reported the subject device would not power up.The reported issue occurred while preparing the subject device for use during an unspecified procedure.There was no patient or user injury reported due to the event.The device was returned to an olympus service center for evaluation.During inspection and testing, service confirmed the device would not power up due to a power unit failure.In addition, service found the fuse box had burn marks and the ac power inlet was burned.
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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.The device manufacture date is unknown, therefore, the device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the legal manufacturer's investigation, the phenomenon was reproduced.It was presumed that the event occurred due to a converter failure.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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