—#210743

Product

Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.

FDA product code: FDS — Gastroscope And Accessories, Flexible/Rigid
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K232997
Affected lot / code info: Model: GIF-1TH190, UDI-DI: 04953170343360, Serial #: Less than 2446103.

Why it was recalled

To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified when completing a Human Factors evaluation of the GIF-1TH190.

Root cause (FDA determination)

Reprocessing Controls

Action the firm took

On October 18, 2024 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions Required: Our records indicate that your facility has purchased one or more of the affected products. The range of affected serial numbers is included at the top of this letter. Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. Implement use of the enclosed Addendum stating that the channel drying time has been extended by 12 minutes to purge water from the channels. This is accomplished by drying each channel for 3 minutes, in the sequence described in the addendum. Ensure all reprocessing personnel are completely knowledgeable and thoroughly trained on the new water purge requirements. 3. Olympus requests that you acknowledge receipt of this letter. Acknowledge receipt of this letter through the Olympus web portal: a. Go to https://olympusamerica.com/recall b. Enter the recall number "0461 c. Complete the form as instructed and include your account ID number: [XXXXXXXX] 4. If you have further distributed this product, identify your customers, and forward them this notification. Olympus requests that you report any complaints, including infections or persistent microbial colonization associated with any Olympus endoscope to the Technical Assistance Center (TAC) at 1- 800-848-9024 (option 1), and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me by phone at (647) 999-3203 from Monday through Friday, 9 am to 5 pm EDT, or by e-mail at Cynthia.Ow@olympus.com.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: Domestic: US Nationwide Distribution.

Timeline

Recall initiated: 2024-09-18
Posted by FDA: 2024-11-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210743. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.