—#196728

Product

HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S

FDA product code: FJL — Resectoscope
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K171965
Affected lot / code info: Model Number/ UDI-DI/ Lot Number WA22602S 14042761085127 1000090824 WA22603S 14042761085134 1000092201 WA22621S 14042761085172 1000080316 WA22657S 14042761085301 1000092202

Why it was recalled

An incompatible HF cable may be packaged with the HF Resection Electrodes. This cable cannot be connected to the electrosurgical generator and may lead to delay or cancellation of the surgical procedure.

Root cause (FDA determination)

Packaging process control

Action the firm took

On November 4, 2022, the firm notified affected customers. Customers were instructed to identify any affected product in their inventory. Affected product should be returned to Olympus, who will issue a credit to the customer upon return of affected product. Those who have distributed the devices outside their facility should notify their customers of this removal action immediately. To return product, contact your Olympus customer service representative at 1-800-848-9024.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide domestic distribution.

Timeline

Recall initiated: 2022-11-04
Posted by FDA: 2022-12-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196728. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.