—#196110

Product

Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.

FDA product code: HHK — Curette, Suction, Endometrial (And Accessories)
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
510(k) numbers: K171440
Affected lot / code info: UDI-DI: 00821925010475 All units are included.

Why it was recalled

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 (FDA determination)

Labeling design

Action the firm took

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 associated with using non-compatible collection canisters and/or accessories and remind them to follow the list of compatible accessories outlined in Section 11 of the IFU. Olympus requests that you acknowledge receipt of this letter by accessing the Olympus recall portal. " Go to https://olympusamerica.com/recall. Enter the recall number 0414 " Enter your name and mailing address. Olympus will supply a copy of the revised IFU at a later date If you have distributed these devices outside your facility, please notify your customers of this matter immediately. If you have any questions, call (647) 999-3203 or email: Cynthia.Ow@Olympus.com for any additional information or support concerning this matter.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: Domestic distribution nationwide. Foreign distribution to Canada and Japan.

Timeline

Recall initiated: 2022-09-16
Posted by FDA: 2022-10-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196110. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.