Device was received for evaluation.Evaluation of the device found that the 'a' rubber glue was peeling off and threads were showing.The c body distal end of the bending section was observed to be detached.In addition, dents and scratches on the plastic were observed.Minor scratches were found on the light guide.The identified parts were replaced, device was repaired.Once completed, the device was tested and passed all required testing and specifications.Based on evaluation findings the reported issue was confirmed.The likely cause of the issue was due to mishandling.
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This supplemental report is being submitted to provide the legal manufacturer investigation.Please see updated sections: g4, g7, h2, h3, h6 and h10.It was reported that the device 'a' rubber was peeling off, parts falling off on the distal end.We are not able to determine an exact root cause for the reported failure.The probable cause is due to an external force applied on the device resulting in damage.Per user¿s manual: it states: before each case, prepare and inspect this endoscope as instructed in the ifu(instruction for use) inspect other equipment to be used with this endoscope as instructed in their respective instruction manuals.Should any irregularity be observed after inspection, if this endoscope malfunctions, do not use it.Return it to olympus for repair.Using an endoscope that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage.This endoscope was not reprocessed before shipment.Before using this endoscope for the first time, reprocess it according to the instructions as described in the endoscope¿s companion ¿reprocessing manual¿ with your endoscope model listed on the cover.".
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