Class 2 Device Recall KARL STORZ NEUROFIBERSCOPE

• Date Initiated by Firm: August 27, 2019
• Create Date: March 20, 2020
• Recall Status: Open, Classified
• Recall Number: Z-1530-2020
• Recall Event ID: 84896
• 510(K)Number: K002788
• Product Classification: Endoscope, neurological - Product Code GWG
• Product: Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope
• Code Information: All Lots
• Recalling Firm/ Manufacturer: Karl Storz Endoscopy; 2151 E Grand Ave; El Segundo CA 90245-5017
• For Additional Information Contact: Customer Service; 800-421-0837 Ext. 5350
• Manufacturer Reason for Recall: During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E (SS1E) sterilization method within the instruction manual is incorrect. If the user uses SS1E to sterilize the impacted scopes and referred to the manual concerning the QCK information, the sterility of reprocessed scope cannot be guaranteed.
• FDA Determined Cause: Error in labeling
• Action: On 8/27/2019 the firm sent an "Urgent Medical Device - Correction" letter detailing the recall was mailed to consignees. In addition to addressing the recall it asked customers to do the following: 1. If you use STERIS SS1E to sterilize the above scopes, and if you selected the specific QCK and tray according to the KARL STORZ Instruction Manuals, please be aware that the sterility of the scope cannot be guaranteed and that you should consider taking necessary actions to address any patient safety concerns. 2. Other than STERIS SS1E system, these scopes can also be sterilized via EtO, STERRAD Systems (NX, 100S and 100NX), V. PRO maX and V. PRO 60. If you use any of these sterilization methods, the QCK error should have no safety impact to your patients. 3. If you have experienced any adverse event with the above scopes, please let us know and at the same time, follow the FDAs MedWatch Adverse Event Reporting process at: https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems#voluntary 4. Attached with this letter we are providing you a copy of the newly revised Instruction Manual for the scope(s) you have received. They are: -11005BC1 Flexible Bronchoscope Print Control #Z21493US-BA -11161C2 Flexible Neuroscope Print Control #Z21491US-BA -11282BN1 Flexible Pediatric Neuroscope Print Control #Z21491US-BA 5. Please be sure to use only the above listed manuals and discard all others. If you would like to receive additional copies, please contact our Technical Support at 800-421-0837, Ext. 5350. If you have any patient safety questions please do not hesitate to contact our Chief Medical Officer, Dr. Dennis Fowler, at 424-218-8603.
• Quantity in Commerce: 73 scopes
• Distribution: US: AL, AZ, CA, CO, CT, DE, FL, GA, IL, IN, MA, MD, MI, MN, MO, NC, NH, NJ, OH, OR, PA, SC, TN, TX, VA, WA, WI, WV, OUS: Canda
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GWG and Original Applicant = KARL STORZ ENDOSCOPY-AMERICA, INC.