—#180281

Product

Olympus Pleuravideoscope, Model LTF-240

FDA product code: GCJ — Laparoscope, General & Plastic Surgery
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K013617
Affected lot / code info: All Serial numbers

Why it was recalled

There was no data to validate that the identified endo-therapy devices were compatible with certain pleuravideoscope models. Updated Operations Manuals are being provided.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

An Urgent Medical Device Correction notification letter dated 3/23/20 was sent to customers. Actions to be taken by the user: Our records indicate that your facility has purchased one or more of the above-referenced endoscopes. OLYMPUS requires that you take the following actions: a) Inspect your inventory of operation manuals for the referenced Olympus models and discard the existing ones. b) Exchange them with the updated, enclosed Operation Manuals having an updated system chart indicating compatible endoscope accessories. c) Notify related personnel at your institution that they should stop the combination use of the LTF-160 and LTF-240 and the subject Endo-Therapy accessories. d) Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number Recall-0066 and provide your contact information as indicated in the portal. e) If you have further distributed this product, identify your customers, forward them this notification including the attachments, and appropriately document your notification process. Olympus regrets any inconvenience caused and fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me directly at (484)896-5688 from Monday till Friday 8AM ET to 5PM ET or by e-mail at laura.storms@olympus.com.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy PO Box 610, Center Valley, Pennsylvania 18034-0610

Distribution

Distribution pattern: US Nationwide

Timeline

Recall initiated: 2020-03-23
Terminated: 2021-11-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180281. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.