Z-0829-2012

Olympus Endoscopic Electrosurgical Unit working elements, model numbers WA22366A, and WA22367A. Working...

Name: Z-0829-2012 Olympus Endoscopic Electrosurgical Unit working elements, model numbers WA22366A, and WA22367A. Working...
Creator: Olympus America Inc.
Published: 2011-12-27
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2011-12-27 / Terminated / root cause: design

FDA source

Olympus America Inc. began a recall of Olympus Endoscopic Electrosurgical Unit working elements, model numbers WA22366A, and WA22367A. Working element for cutting, coagulation, and vaporization in... on 2011-12-27. The reason FDA records is "Less than optimal thickness in the plastic housing holding the electrode in the Olympus Working Elements". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0829-2012
Status: Terminated
Initiated: 2011-12-27
Posted: 2012-01-20
Terminated: 2013-12-21
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus Endoscopic Electrosurgical Unit working elements, model numbers WA22366A, and WA22367A. Working element for cutting, coagulation, and vaporization in conductive irrigation fluid or conductive distension medium in the Saline mode.
Product code: KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Reason for recall: Less than optimal thickness in the plastic housing holding the electrode in the Olympus Working Elements
Root cause tag: design
FDA root cause: Component design/selection
Action: Olympus America Inc. sent an "URGENT: MEDICAL DEVICE WITHDRAWAL" letter dated December 27, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to inspect their inventory for the affected product and discontinue use of any affected product discovered. Customers should contact the Gyrus ACMI Customer Service Department at 1-888-524-7266 for credit or replacement of the product. Additionally, an Olympus Working Elements Withdrawal form was enclosed for customers to complete and fax to 484-896-7128. Contact the firm at 484-896-5688 for questions regarding this notice.
Distribution: Nationwide Distribution-including Washington, D.C. and the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MI, MN, MO, MT, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, and WI.
Product codes and lots: Lot numbers 118W, 119W, and 11XW for new inventory

Product code KNS

K030194Class IIXues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. / cleared 2003-03-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)