FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1

The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port.

A safety alert was sent to all affected consignees on 7/26/209 via FED Ex. The safety alert informed consignees of the following: 1. From the reprocessing point of view, depending on the methods of reprocessing at your facility, the scope built with the incorrect port may impact the reprocessing outcome. 2. When using STERIS System for sterilization, the above QKC connectors connect onto one port, and leaving the other QKC connector open. The STERIS system, however, will complete the cycle without any indication of a problem, yet the sterility of the scope cannot be guaranteed. If you use STERIS SS1E to reprocess this scope, please be aware of the possible risks and take the necessary actions to address any patient safety concerns. 3. Please complete the attached Immediate Action Requested form and follow the instructions outlined on the form. If you have experienced any adverse event with the scope, please let us know and at the same time following the FDAs MedWatch Adverse Event Reporting process, https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems#voluntary. 4.If your scope is CORRECT, no other actions needed. If your scope is INCORRECT, our Customer Support will contact you and provide you an RMA number to return your scope to us, and at the same time arrange a no charge replacement sent to you via overnight delivery. 5. If you have any questions please contact the following person: Reprocessing Shaun McGinley, Director of Reprocessing 424-218-8247 Patient Safety Dr. Dennis Fowler, Chief Medical Officer 424-218-8603