Recall Z-2540-2024— Olympus Corporation of the Americas

Name: FDA recall Z-2540-2024
Creator: U.S. Food and Drug Administration
Published: 2024-07-01

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2024-07-01. It names one FDA 510(k) clearance: K023492. Product: The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of compatible generators. The forceps' jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad. To transect tissue, a cutting blade is actuated and moves between the electrode jaws. The connections (bipolar electrical signal) to the forceps are through either a hardwired cable (model 3006) or a connector at the bottom of the handle (models 3000 and 3005). The device includes mechanisms (switches and triggers) to provide coagulation using the bipolar electrical energy that reaches the forceps. The forceps are positioned in the desired location for grasping, coagulation, and transection of tissue. The anatomical structure to be coagulated is placed between the open forceps jaws, and once the Forceps Grip trigger is squeezed, the forceps' jaws are closed onto tissue, followed by coagulation. The device includes a blade that is mechanically advanced to perform tissue cutting as needed.. Reason: Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach.

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2024-07-01
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K023492 — EVEREST BIPOLAR CUTTING FORCEPS AND GYRUS BIPOLAR CUTTING FORCEPSGyrus Medical, Inc.·cleared 2002-11-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of compatible generators. The forceps' jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad. To transect tissue, a cutting blade is actuated and moves between the electrode jaws. The connections (bipolar electrical signal) to the forceps are through either a hardwired cable (model 3006) or a connector at the bottom of the handle (models 3000 and 3005). The device includes mechanisms (switches and triggers) to provide coagulation using the bipolar electrical energy that reaches the forceps. The forceps are positioned in the desired location for grasping, coagulation, and transection of tissue. The anatomical structure to be coagulated is placed between the open forceps jaws, and once the Forceps Grip trigger is squeezed, the forceps' jaws are closed onto tissue, followed by coagulation. The device includes a blade that is mechanically advanced to perform tissue cutting as needed.

Reason for recall

Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach

Data sourced from openFDA. This site is unofficial and independent of the FDA.