Medical device manufacturer, Olympus Medical Systems Corporation (OMSC), has issued a medical device safety alert concerning the Evis Exera II Bronchovideoscope Olympus BF Type 1T180 (BF-1T180) and Evis Exera Bronchovideoscope Olympus BF Type 1T160 (BF-XT160).

The manufacturer reminds the affected users to follow the instructions for manual cleaning and brushing when reprocessing BF-1T180 and BF-XT160 devices. The manufacturer conducted a post-market risk assessment, which showed that due to large channel diameter, both BF-1T180 and BF-XT160 are associated with a potential risk of patient infection due to inadvertent retention of biomaterial when manual cleaning and brushing are not performed as instructed. If reprocessed according to the instructions for use, the manufacturer is not aware of any signals that would suggest these devices pose unacceptable risks to patients or users versus the benefits that users have come to trust and rely upon.

Affected users should ensure that all reprocessing personnel are completely knowledgeable and thoroughly trained on the reprocessing instructions in the BF-1T180 and BF-XT160 reprocessing manuals. The manufacturer requests users to report any patient injuries, including infections or persistent microbial colonization associated with any OMSC endoscope.

The manufacturer provides the following services to affected users if they require additional information about the proper steps to clean and reprocess the BF-1T180 and BF-XT160:

• The manufacturer's staff can assist in answering BF-1T180 and BF-XT160 cleaning and reprocessing questions and provide additional copies of the BF-1T180 and BF-XT160 reprocessing manuals and supplemental educational materials. Users should note that the BF-1T180 has been validated for manual cleaning, high level disinfection (HLD), ethylene oxide (EO) sterilization and STERRAD NX, and the BF-160 has been validated for manual cleaning, HLD and EO sterilization.
• The manufacturer's staff can conduct a site visit to assess and observe customer reprocessing methods and to provide reprocessing training and education, and also conduct training on endoscopy, with courses on endoscope reprocessing for both nurses and reprocessing specialists.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 17 September 2020