Model Number CLV-S40PRO |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/07/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Olympus field services investigated the subject device at user facility and followings were obtained.-the xenon lamp glass was broken.-the xenon lamp was not set appropriately.The subjected device was returned to olympus medical systems corp (omsc) for evaluation.Omsc is investigating the subject device.Clv-s40pro instruction manual states the corresponding method in case of an abnormality.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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Olympus was informed that the following information.During video assisted thoracic surgery, the breaking sound was occurred form the subject device.The endoscopic image became dark and the emergency lamp of the subject device was turned on.The user facility replaced the subject device with unspecified another system, and completed the procedure.There was no report of the patient¿s injury regarding this event.
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Event Description
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Olympus was informed the following information.An unspecified another system that the user used after the replacement was the visera pro system.
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Manufacturer Narrative
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The lamp in the subject clv-s40pro was returned to the manufacturer for the detailed investigation.The manufacturer reported the following investigation result to omsc.The glass of the lamp broke under the abnormal use.The stress was applied to the outer circumstance of the lamp because the lamp was attached to the heat sink diagonally.Consequently, the lamp was difficult to cool.It was surmised that the glass broke because the part under the stress was unable to withstand the thermal expansion.Based on these investigations, omsc surmised this event occurred by the following.The user did not attach the lamp to the heat sink properly.Therefore the reported result from the manufacturer 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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