This report for non-fatal serious injury/device malfunction has been stored under the covid-19 pandemic in accordance with the guidance published by fda, postmarketing adverse event reporting for medical products and dietary supplements during a pandemic.Omsc reviewed the manufacturing history (dhr) of the device and confirmed no irregularity.The facility uses ecolab pureclean neutral detergent to manually clean the devices.They also use schulke thermosept detergent for automated endoscope reprocessing machine distributed by cantell.The devices were returned to olympus.Olympus tested them at a laboratory.The results reported that the devices tested negative for microorganisms and the black foreign materials derived from rubber , but not from microorganisms.The laboratory also reported that chemicals used for endoscope reprocess could produce the black substances.The devices were then returned to the customer after repair.Olympus performed on-site investigation and found that some components coming from rubber and copper were detected in the facility's sink used for the endoscope reprocessing.The exact cause of the reported event could not be conclusively determined.However, based on the information above, sterilizing the endoscopes with rubber and copper adhered to the distal end was likely to produce the black substances.In order to address the issue, the customer will check if no foreign materials adhere to the surface of the devices and make sure that the devices are completely dry.If additional information becomes available, this report will be supplemented.
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