Recall Z-0078-2023 ยท HHK Curette, Suction, Endometrial (And Accessories)
Olympus Corporation of the Americas
Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
| Date | Oct 12, 2022 (initiated Sep 16, 2022) |
| Status | Open, Classified |
| Reason | Update to the Instruction for Use (IFU): Olympus is adding a new warning against the use of accessories which are not listed in the IFU. There have been reported adverse events involving the use of collection canisters which were not designed for use with the VC-10, which can lead to serious injuries as it does not fit properly with the VC-10. |
| Root cause | Labeling design |
| Action | On September 16, 2022, the recalling firm notified affected customers through "URGENT Medical Device Field Corrective Action" letters. Customers were informed that the following new warning will be added to the IFU: Do not use replacement parts or accessories that are not compatible with the VC-10 system. Use of noncompatible accessories could lead to reduced system functionality and/or patient injury such as perforation, bleeding, and may require additional intervention. Refer to Section 11 for all accessories compatible with the VC-10 system. Customers should notify their users about risks |
| Quantity | 4184 US; 191 OUS |
| Distribution | Domestic distribution nationwide. Foreign distribution to Canada and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171440 | Berkeley VC-10 Vacuum Curettage System Gyrus Acmi, Sep 29, 2017 |