Recall Z-2629-2017 ยท GCP Endoscope, Ac-Powered And Accessories
Olympus Corporation of the Americas
High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.
| Date | Apr 19, 2017 |
| Status | Terminated |
| Reason | Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes. |
| Root cause | Under Investigation by firm |
| Action | Olympus sent an Urgent Medical Device Removal Notice dated April 26, 2017, to affected customers to inform them of the issue. The notice identified the issue, the actions to be taken by the end user. It advised that customers discontinue use of any affected electrodes if found, contact Olympus Customer Care Center and they will provide instructions on how to return the affected product as well get a free replacement. Customer were instructed fax the completed reply from to 484-896-7128. Customer with questions should call 484-896-5688. For questions regarding this recall call 484-896-5000 |
| Quantity | 1264 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K790071 | ENDOSCOPE AND ACCESSORIES Olympus Corp., Apr 2, 1979 |