Recall Z-0697-2024 ยท HET Laparoscope, Gynecologic (And Accessories)
Olympus Corporation of the Americas
Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.
| Date | Jan 10, 2024 (initiated Nov 6, 2023) |
| Status | Open, Classified |
| Reason | Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual impacts mucosal injury or bleeding may occur. |
| Root cause | Component design/selection |
| Action | UPDATE: On 2/9/24 Olympus issued Correction to original letter dated November 6, 2023, regarding the IFU references in #2. The purpose of this Field Corrective Action is to reinforce the requirement in the IFU that users inspect the image prior to a clinical procedure (as described in Section 4.3.3 and 4.4), always have a spare laparoscope available (as described in Section 2.5 General Safety Notes) and to check the image for the spare equipment. Olympus issued Urgent Medical Device Correction letter on November 6, 2023 to US Operating Room Manager, Risk Management Department. Letter state |
| Quantity | WA50040A : 561 units; WA50042A: 857 units |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190744 | ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) Olympus Winter & Ibe GmbH, Aug 29, 2019 |