Recall Z-0334-2024 ยท FDF Colonoscope And Accessories, Flexible/Rigid
Aizu Olympus Co., Ltd.
Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151,
| 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 | 3627 units |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011151 | EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z The Olympus Optical Co., May 15, 2001 |
| K051645 | EVIS EXERA 160A SYSTEM Olympus Medical Systems Corporation, Oct 13, 2005 |
| K100584 | EVIS EXERAII 180 SYSTEM Olympus Medical Systems Corporation, Jul 2, 2010 |
| K111756 | V1 SYSTEM Olympus Medical Systems Corp., Mar 20, 2012 |
| K112680 | EVIS EXERA III VIDEO SYSTEM Olympus Medical Systems Corporation, Feb 16, 2012 |
| K954451 | EVIS 140 SYSTEM Olympus America, Inc., Mar 29, 1996 |