Model Number CLV-U20D |
Device Problem
No Device Output (1435)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/17/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The subject clv-u20d will be returned to olympus medical systems corp.(omsc) for the evaluation.Omsc continues to investigate this event.Clv-u20d instruction manual states the corresponding method in case of an abnormality.There were no further details provided.If significant additional information is found, this report will be supplemented.
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Event Description
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The subject clv-u20d was used for the knee arthroscopic surgery.The subject clv-u20d was turned off after 5 minutes from using the subject clv-u20d.The user replaced the subject clv-u20d with unspecified another device and completed the procedure.The user commented that the user could not hear the sound of the cooling fan in the subject clv-u20d during the procedure.There was no report of the patient¿s injury regarding this event.
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Manufacturer Narrative
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The subject clv-u20d was returned to olympus medical systems corp.(omsc) for the evaluation.Omsc tried to reproduce this phenomenon and found the following.This phenomenon was reproduced.The subject clv-u20d was turned off after 10 minutes from ignited the lamp in the subject clv-u20d.There was no sound of the fan moving of the subject clv-u20d.The subject clv-u20d had been 25 years since installation.In addition, the subject clv-u20d was not repaired from april 2001.Based these investigation results, omsc surmised that this phenomenon might have been occurred by following.-the internal temperature of the subject clv-u20d increased because the fan of the clv-u20d was not functioned.Due to increasing temperature, the overheat protection mechanism was functioned and the subject clv-u20d was turned off.The fan and/or the circuit of the fan was failed because of aged deterioration.Therefore this phenomenon occurred.There were no further details provided.If significant additional information is found, this report will be supplemented.
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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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