This supplemental report is being submitted to provide additional information.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The legal manufacturer reported that from the investigation result, there is a trace of a-rubber and gluing part repair done by a party that is not certified by olympus.As a consequence, the subject device was not in a condition that the durability is guaranteed by olympus.It is presumed that non-genuine a-rubber and gluing part was damaged by the physical and chemical stress.The legal manufacturer reported that the caution about a third party repair is described in the ifu.It is recommended to re-instruct the customer that repair should be performed by persons who are qualified by olympus.As well as how to inspect the scope for damage.Effect of misuse the following detecting method for the subject event is described in the ifu.It is determined that the reported event was properly detected according to the ifu.3.3 inspection of the endoscope : inspect the external surface of the entire insertion section, including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.The ifu has the following description regarding repair.It was confirmed that the repair done to the device deviated from the ifu.5.2 troubleshooting guide: as repair performed by persons who are not qualified by olympus could cause patient or user injury and/or equipment damage.As the result of dhr review done by mbc, the subject device¿s conformity to the shipping test was confirmed.
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