This report for non-fatal serious injury/device malfunction has been stored under the covid-19 pandemic in accordance with the guidance published by fda, postmarketing adverse event reporting for medical products and dietary supplements during a pandemic.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, based upon the information from (b)(6), there was the possibility that the reported phenomenon was attributed to the unreasonable installation of the unspecified xenon lamp by the user.
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Olympus medical systems corp.(omsc) was informed from the user that during the periodic inspection of the subject device, the electrode in power supply module was damaged.Also, in the module was mounted wrong type of the xenon lamp (b)(4).There was no report of patient injury associated with this event.
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