Olympus medical systems corp.(omsc) was informed by the health professional that after reprocessing the subject device, the following event occurred.It was found a black foreign object.After removing the foreign object, the reprocessing was performed again, but a black foreign object was found.There was no patient injury reported.
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This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Black foreign matter was attached to the sterilization pack.When the check of the coating part of the operation wire, there was a part of the black coating that had peeled off and a part that was about to peel off.When the coated part of the operation wire was rubbed with a non-woven fabric, a part of the coating that was about to peel off was peeled off and adhered to the non-woven fabric as a black foreign substance.The manufacturing record was reviewed and found no irregularities.From the actual device confirmation result, it is presumed that the black foreign matter you pointed out is the coating (coating) of the peeled operation wire.Therefore, it is not necessary to analyze the components of black foreign matter.From the state of the actual product, it is presumed that the peeling of the coating on the operation wire was caused by factors such as the coating part being rubbed against a hard object during use or reprocessing, but it was not possible to identify.The above device handling has warned in the instruction manual.
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