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Moderate riskFDA DeviceClass II

Olympus Everest Bipolar Cutting Forceps recalled for defective welds causing jaw breakage

Olympus has recalled its Everest Bipolar Cutting Forceps (Model 3005) used in minimally invasive surgery because some units contain defective welds in their components. The jaw of the forceps can break during use due to these faulty welds. This affects 106 units distributed worldwide.

From the FDA notice · Read the official notice ↗ · All Olympus recalls

What to do

  1. Stop using Olympus Everest Bipolar Cutting Forceps Model 3005 immediately
  2. Check your facility's inventory for affected units (all unexpired lots from supplier are recalled)
  3. Contact Olympus Corporation of the Americas for instructions on replacement or return
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators.
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 7 products — see all of them.

Details

Units affected
106 units
Illnesses reported
None reported
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Classification
Class II
Recall number
Z-1638-2026

In the FDA's words

Description
Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the bipolar outputs of compatible generators. Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use. Model: 3005; UDI: 00821925035881; Lot Number: All unexpired Distribution: Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan. Affected quantity: 106 units
Hazard
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

7 products in this recall

Olympus cutting forceps recalled for jaw breakage risk

Olympus is recalling seven models of bipolar and PK/PKS cutting forceps, 3,788 units in total, used in medical procedures. The supplier did not adequately validate a welding process for components, and defective welds could cause the forceps' jaw to break during clinical use. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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