Model Number CLV-260SL |
Device Problems
Gas Output Problem (1266); No Flow (2991)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/04/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The subject clv-260sl does not return to olympus.There were no further details provided.If significant additional information is received, this report will be supplemented.
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Event Description
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During the unspecified procedure with the clv-260sl, the air feeding of the subject clv-260sl through the unspecified endoscope could not be operated.The user replaced the subject clv-260sl to an unspecified similar system and completed the procedure using the same endoscope.There was no report of the patient¿s injury regarding this event.The local service engineer reported the following evaluation result of the subject clv-260sl.The excessive dust collected inside the subject clv-260sl.The air pump incorporated in the subject clv-260sl was faulty.The phenomenon that the user mentioned was reproduced.
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Manufacturer Narrative
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This is a supplemental report for mfr report #8010047-2018-02569.The subject clv-260sl was not returned to olympus medical systems corp.(omsc).The root cause of this event could not be conclusively determined, because omsc could not investigate the subject clv-260sl.Omsc checked the device history record of the subject device, and there was no irregularity found.As ten years or more has passed since the manufacture date of the subject clv-260sl, omsc surmised that the air pump incorporated in the subject device was faulty by aging degradation or other.The instruction manual of the clv-260sl states the corresponding method in case of an abnormality.
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Manufacturer Narrative
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This supplemental report is submitting to correct "device product code".
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Search Alerts/Recalls
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