Model Number MD-631 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc will start evaluating the device.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 hysteroscopic surgery with clv-s190 using the device (xenon lamp md-631), there was a bursting sound and the device went off.The emergency lamp of the clv-s190 stated up.The user completed the procedure by using the clv-s190.There was no report of patient injury associated with the event.The device was broken.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc confirmed cracks over the entire surface of the lens of the subject device.Omsc confirmed that four years or more have passed since the subject device was manufactured.The exact cause of the reported phenomenon could not be conclusively determined.However, it is surmised that the reported phenomenon was attributed to an accidental failure or over heated due to dust on the heat exhaust of the light source.
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Search Alerts/Recalls
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