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Berkeley VC-10 Vacuum Curettage System, Model No. VC-10.… recallZ-0078-2023 · Olympus Corporation of the Americas · initiated Sep 16, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Labeling design

What the company is doing

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: [email protected] for any additional information or support concerning this matter.

Recall details

Recall number
Z-0078-2023
Status
Open, Classified
Initiated by the company
Sep 16, 2022
Posted by the FDA
Oct 12, 2022
Recalling firm
Olympus Corporation of the Americas
Quantity
4184 US; 191 OUS
Product code
HHK
FDA submissions
K171440
Distribution
Domestic distribution nationwide. Foreign distribution to Canada and Japan.

Product description

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

Code information (models, lots, serial numbers)

UDI-DI: 00821925010475 All units are included.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

6 devices cleared under K171440 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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