Distal Cover & Evis Exera III Duodenovideo Scope (2021-02-05)

Starting date:

February 5, 2021

Posting date:

February 19, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-75017

Last updated: 2021-02-19

• Reason
• Affected products

Affected Products 

A. Distal Cover
B. Evis Exera III Duodenovideo Scope

Reason

Olympus Medical Systems Corp. has identified an increase in the number of complaints from customers reporting that mucosal tissue was found within the single-use distal cover, MAJ-2315, after withdrawing the TJF-Q190V duodenoscope from the patient. In the reported complaints, the user facilities have reported mucosal injuries in the esophagus, stomach, and duodenum. Although most of the injuries reported did not necessitate additional treatment, two cases did require medical intervention: Proton Pump Inhibitor medication in one case and endoscopic therapy (such as clipping) in the another case. Olympus is thoroughly investigating the root cause or causes of these reported events. However, in the interest of transparency and to support the continued safe use of these devices, Olympus will send a letter to remind customers to follow the Instruction for Use and, where appropriate, to consider and follow information and recommendations supplied in the letter that may reduce the potential occurrence of similar incidents.

Affected products