Recall Z-0829-2012 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Olympus America Inc.
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.
| Date | Jan 20, 2012 (initiated Dec 27, 2011) |
| Status | Terminated |
| Reason | Less than optimal thickness in the plastic housing holding the electrode in the Olympus Working Elements |
| 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030194 | XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT The Olympus Optical Co., Mar 24, 2003 |