Recall Z-0747-2012 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Olympus America Inc.
Olympus Electrosurgical Unit. The Olympus Electrosurgical Unit (ESG-100) is used in conjunction with cutting and coagulation electrosurgical devices intended for use in electrosurgery procedures during flexible gastrointestinal endoscopy.
| Date | Jan 13, 2012 (initiated Nov 28, 2011) |
| Status | Terminated |
| Reason | Investigations of customer complaints revealed a counterfeit capacitor was used in the manufacture of some lots of the ESG-100. |
| Root cause | Nonconforming Material/Component |
| Action | Olympus America Inc. sent an URGENT: MEDICAL DEVICE CORRECTION ACTION" letter dated November 28, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of the affected product. A questionnaire was attached to the letter for customers to complete and return via fax at 484-896-7128. Contact the firm at 484-896-5000 for questions regarding this notice. |
| Quantity | 245 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073207 | OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167 Celon AG Medical Instruments, May 8, 2008 |