Recall Z-0341-2024 ยท NWB Endoscope, Accessories, Narrow Band Spectrum
Aizu Olympus Co., Ltd.
Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). Model Numbers: PCF-H180AI, PCF-H180AL, PCF-H190DI, PCF-H190DL, PCF-H190I, PCF-H190L, PCF-H190TI, PCF-H190TL, PCF-HQ190I, PCF-HQ190L, PCF-PH190I, PCF-PH190L, PCF-Q180AI, PCF-Q180AL, PCF-S.
| Date | Nov 17, 2023 (initiated Sep 25, 2023) |
| Status | Open, Classified |
| Reason | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection |
| Root cause | Under Investigation by firm |
| Action | Olympus America issued Urgent Medical Device Correction letter on Sept. 25, 2023 to Endoscopy, Respiratory, Pulmonary and Urology Departments, Risk Management Department. Letter states reason for recall, health risk and action to take: Our records indicate that Olympus has serviced your flexible endoscope at one of our Olympus repair facilities. Following repair activities, Olympus uses a water flush of endoscope channels as part of our final endoscope channel inspection, and we subsequently dry the endoscope channels with compressed filtered air. Olympus discovered that our channel air drying |
| Quantity | 3101 units |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131780 | EVIS EXERA III VIDEO SYSTEM Olympus Medical Systems Corp., Aug 29, 2013 |
| K192793 | Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III C Olympus Medical Systems Corp., Jul 17, 2020 |
| K980465 | OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS Olympus America, Inc., Apr 21, 1998 |