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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 FIBERSCOPE see related information
Date Initiated by Firm February 20, 2019
Create Date August 28, 2019
Recall Status1 Terminated 3 on July 07, 2020
Recall Number Z-2425-2019
Recall Event ID 83459
510(K)Number K002788  
Product Classification Endoscope, neurological - Product Code GWG
Product FLEXIBLE 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
Recalling Firm/
Manufacturer		 Karl Storz Endoscopy
2151 E Grand Ave
El Segundo CA 90245-5017
For Additional Information Contact Ms. 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
Action 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
Quantity in Commerce 22 scopes
Distribution US: FL, MO, MA, AL,CA, OH, PA,NH, OR, WA, MI, NC, CA, VA
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GWG and Original Applicant = KARL STORZ ENDOSCOPY-AMERICA, INC.
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