This report is being supplemented to provide additional information based on the legal manufacturer's device evaluation and investigation.Based on the results of the device evaluation, the reported event was confirmed.It has been over 7 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a definitive root cause of the reported event could not be identified.However, it¿s likely the cause is related to irregular stress applied to the distal end during device handling by the user.The suggested event is detectable and preventable by handling the device in accordance with the following instructions for use: -ifu: gif-h190, pcf-h190l/i reprocessing manual chapter 5 reprocessing the endoscope (and related reprocessing accessories) 5.4 leakage testing of the endoscope olympus will continue to monitor field performance for this device.
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