Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and il

FDA device recall Z-0341-2024 · posted 2023-11-17 · Open, Classified

Recall details

Recalling firm

Aizu Olympus Co., Ltd.

Reason for recall

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

Action taken

Olympus America issued Urgent Medical Device Correction letter on Sept. 25, 2023 to Endoscopy, Respiratory, Pulmonary and Urology Departments, Risk Management Department. Letter states reason for recall, health risk and action to take: Our records indicate that Olympus has serviced your flexible endoscope at one of our Olympus repair facilities. Following repair activities, Olympus uses a water flush of endoscope channels as part of our final endoscope channel inspection, and we subsequently dry the endoscope channels with compressed filtered air. Olympus discovered that our channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Olympus is in the process of implementing a validated drying process at our repair centers. In the meantime, Olympus has established interim processes to perform an additional inspection of your scope for water prior to return. 1. Ensure your users are knowledgeable on the content of this letter. 2. Complete the enclosed response form and return it to our recall partner, Sedgwick, via e-mail at olympus2806@sedgwick.com or by fax at 844-294-7184. For any questions about the acknowledgement form, please call the Sedgwick team at 888-667-1504. 3. Olympus requests that you report complaints, including infections, and endoscopes returned wet from our repair centers to Olympus. Please report complaints to Technical Assistance Center (TAC) at 1-800-848-9024, option 1. Adverse events experienced with the use of this product may also be reported to the Food and Drug Administration MedWatch Adverse Event Reporting program either online, by regular mail or by fax. If you require additional information, please do not hesitate to contact me at (647) 999-3203 or Cynthia.Ow@Olympus.com.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

NWB

Quantity affected

3101 units

Distribution

Worldwide - US Nationwide distribution.

Date initiated

2023-09-25

Date posted

2023-11-17

Location

Aizuwakamatsu, 3 Chome, Japan

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