EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V

FDA device recall Z-2467-2023 · posted 2023-08-28 · Open, Classified

Recall details

Recalling firm

Olympus Corporation of the Americas

Reason for recall

Recent reports of patient infection.

Action taken

Consignees were sent an Urgent Medical Corrective Action notification dated 7/27/2023. This action is being initiated due to the firm becoming aware of and FDA inquiring about recent reports of infections and positive cultures. Olympus is reminding users to closely follow reprocessing instructions, including periodic inspections by Olympus Service, and informing users about an updated manual intended to improve comprehension of existing reprocessing steps. Additional enhancements to the manual include the use of reprocessing timelines and simplified text/visualization techniques. The manual is available on the customer web portal and paper copies, along with wall charts, are available to be mailed to your facility. The notification also emphasises the required inspection of the forceps elevator mechanism, to be performed once a year or every 100 reprocessing cycles, and encourages consignees to consider incorporating voluntary routine microbiologic surveillance of endoscops as part of their quality improvement/assurance efforts. Consignees are asked to complete and return the provided response form to Sedgwick via email at ollympus7521@sedgwick.com or by fax to 888-208-4588. Questions can be directed by phone to 866-912-9552. Customers can also contact Ashley Mitch at Olympus by phone at 484-553-1029 or by email at Ashley.Mitch@olympus.com with any additional concerns.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

FDT

Quantity affected

6,426 units

Distribution

US Nationwide distribution.

Date initiated

2023-07-27

Date posted

2023-08-28

Location

Center Valley, PA

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