Olympus medical systems corp.(omsc) was received the foreign objects and checked and found followings; [investigation results] -the foreign objects of the subject device were translucent, thin, elongated solid, elastic substance.-there was no defect on the subject device other than the reported phenomenon.-it was reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.[cause] the foreign objects of the subject device were translucent, thin, elongated solid, elastic substance.As a result of organic qualitative analysis of foreign objects, it was found that they were silicon-based substances.After confirming the manufacturing process for investigate the cause, it was confirmed that some silicon-based sealants were used in the assembly work of the connector for connecting the connecting tube of the endoscope cleaning and disinfecting device and the internal unit.However, due to the structure of the product, it was confirmed that there was no possibility that the sealant will squeeze out or enter the liquid supply channel, and if there is any abnormality, it can be detected during the inspection of the assembly process.Therefore, it was not possible to identify where the foreign object came from.It was speculated from the above, omsc presumed there was the possibility this phenomenon was attributed to silicon-based foreign object has entered the liquid supply channel at some point including when it was in use.However, it could not be identified the cause of the reported phenomenon.If additional information becomes available, this report will be supplemented.
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