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U.S. Department of Health and Human Services

Class 2 Device Recall FLEXIBLE NEURO FIBERSCOPE

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 Class 2 Device Recall FLEXIBLE NEURO FIBERSCOPEsee related information
Date Initiated by FirmFebruary 20, 2019
Create DateAugust 28, 2019
Recall Status1 Terminated 3 on July 07, 2020
Recall NumberZ-2425-2019
Recall Event ID 83459
510(K)NumberK002788 
Product Classification Endoscope, neurological - Product Code GWG
ProductFLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1
Code Information SERIAL NUMBER: 2161516, 2204079, 2172240, 2198276, 2062041, 2178784, 2198341, 2220959, 2210200, 2183837, 2188370, 2247464, 2248783, 2194154, 2244117, 2039298
FEI Number 3007475226
Recalling Firm/
Manufacturer		 Karl Storz Endoscopy
2151 E Grand Ave
El Segundo CA 90245-5017
For Additional Information ContactMs. Susie S. Chen
424-218-8201
Manufacturer Reason
for Recall		The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port.
FDA Determined
Cause 2		Employee error
ActionA 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
Quantity in Commerce22 scopes
DistributionUS: FL, MO, MA, AL,CA, OH, PA,NH, OR, WA, MI, NC, CA, VA
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = GWG
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