This supplemental report is being submitted to provide additional information.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.Olympus europa se & co.Kg (oekg) confirmed the reported phenomenon and investigated the subject device.The investigation found air leak at the bending rubber, protrusion of a part of the bending braid from the incision of the bending rubber, and break of the bending tube.The exact cause of the reported phenomenon could not be conclusively determined.However, there was the possibility that this phenomenon was attributed to the break of the bending tube that was confirmed in the investigation by oekg.According to the previous investigation for similar case, it was known that the tip of the device was bent and pushed in with excessive force accessing to a lower renal calyx or a ureter, the bending tube might break.
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