Recall Z-1292-2021— Olympus Corporation of the Americas

Name: FDA recall Z-1292-2021
Creator: U.S. Food and Drug Administration
Published: 2021-01-28

Class II · Terminated

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2021-01-28, terminated 2024-03-13. It names one FDA 510(k) clearance: K193182. Product: Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.. Reason: Olympus Medical Systems Corporation (OMSC) has received complaints of mucosal injury associated with the forceps elevator region of the TJF-Q190V duodenoscope, including the distal cover (model MAJ- 2315)..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Terminated
Initiated: 2021-01-28
Terminated: 2024-03-13
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K193182 — Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp.·cleared 2020-01-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

Reason for recall

Olympus Medical Systems Corporation (OMSC) has received complaints of mucosal injury associated with the forceps elevator region of the TJF-Q190V duodenoscope, including the distal cover (model MAJ- 2315).

Data sourced from openFDA. This site is unofficial and independent of the FDA.