—#171747

Product

Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.

FDA product code: EOQ — Bronchoscope (Flexible Or Rigid)
Device class: Class 2
Medical specialty: Ear, Nose, Throat
510(k) numbers: K920025
Affected lot / code info: Lot numbers: 88H, 89H, 8XH, 8YH, 8ZH, 91H

Why it was recalled

There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope.

Root cause (FDA determination)

Process control

Action the firm took

Urgent Medical Device Correction letters dated 4/1/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. For questions call 484-896-5688.

Recalling firm

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

Distribution

Distribution pattern: The products were distributed US Nationwide.

Timeline

Recall initiated: 2019-04-01
Terminated: 2020-06-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171747. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.