Flexible Intubation Fiberscope, Model # 11301AB1
Recall
- Recall Number
- Z-2447-2019
- Event Number
- 83419
- Firm
- Karl Storz Endoscopy
- FEI Number
- 3007475226
- Product Code
- EOQ
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- April 24, 2019
- Terminated
- December 4, 2020
- Address
- 2151 E Grand Ave, El Segundo, CA, 90245-5017
Description
Flexible Intubation Fiberscope, Model # 11301AB1
The action is being initiated due to intubation scopes improperly manufactured with a double port luer instead of a single port luer.
The firm mailed a "safety alert" on April 24, 2019 via FedEx. 2nd day delivery. The safety alert advised customers to do the following: 1. If you use the following automated processes, the high level disinfection/liquid chemical sterilization of the flexible endoscope cannot be guaranteed: Reprocessing Method Impact, Medivators AER * Patient Safety may be Compromised, STERIS System 1E (SS1E)** Patient Safety may be Compromised The above connectors can only connect onto one port, therefore leaving the other port open. Depending on the reprocessing system, the cycle could result in an error or in successful completion of the cycle. " If an error code is displayed, the user would know the cycle is not complete and the scope has not been successfully reprocessed. " If the cycle is completed without an error code, the high-level disinfection/liquid chemical sterilization of the flexible endoscope cannot be guaranteed. Improper reprocessing may result in incomplete decontamination, which may result in a cross-contamination patient infection. If you use Medivators AER or STERIS SS1E to reprocess this scope, please be aware of the possible risks and take the necessary actions to address any patient safety concerns. 2. Please complete the attached Action Requested form and follow the instructions outlined on the form. 3. you have any questions please contact the following person: This Recall Action, Emily Cuadros, Complaint Handling , 424-218-8289 Reprocessing, Shaun McGinley, Director of Reprocessing, 424-218-8247 Patient Safety, Dr. Dennis Fowler, Chief Medical Officer, 424-218-8603
US: VA, MO, CA, OH, NM, NY, CO, LA, ME, OUS: Canada
14 scopes