Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: Designed for use in a medical facility under th
FDA device recall Z-1277-2013 · posted 2013-05-08 · Terminated
Recall details
- Recalling firm
- Olympus America Inc.
- Reason for recall
- Olympus initiated a software upgrade and enhancement in 2009 and completed the action in 2010. The upgrade and enhancement were initiated due to complaints of overheating, smoke vapors and failure to operate associated with the Olympus SurgMaster electrosurgical unit, model UES-40 ("UES-40") when used in conjunction with the Olympus WA22557C electrode. The complaint investigations revealed that
- Action taken
- Olympus America Inc sent a Field Corrective Action letter dated November 10, 2009 to all affected consignees. The letter identified the affected product, problem and actions to be taked. Consignees were directed to contact Gyrus at 888-524-7266 to schedule return of the UES-40 generator for the software upgrade. The letter also directed consignees to contact OAI Customer Service at 800-848-9024 if they needed a new copy of the UES-40 Instruction Manual. For questions call 484-896-5688.
- Root cause
- Use error
- Status
- Terminated
- Product code
- KNS
- Quantity affected
- 608
- Distribution
- Nationwide Distribution - USA Nationwide including the states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, SC
- Date initiated
- 2009-11-10
- Date posted
- 2013-05-08
- Date terminated
- 2013-07-05
- Location
- Center Valley, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT (K030194) | The Olympus Optical Co. | 2003-03-24 |