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Dr KARLSTORZ
The FDA continues to work with other device manufacturers to evaluate potential causes and contributing factors for patient infections associated with reprocessed urological endoscopes and develop mitigation measures to minimize the risk of infection.
KARLSTORZproducts
Urological endoscopes are used by health care providers to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of the urinary tract (for example: urethra, bladder, ureters, and kidneys) depending on the intended use and design of the device.
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On April 1, 2022, Karl Storz initiated a voluntary recall and issued an urgent field safety notice to instruct users to discontinue all high-level disinfection methods for all affected urological endoscopes and discontinue liquid chemical sterilization for most of the affected urological endoscopes. The affected urological endoscopes should be sterilized after each use by an appropriate sterilization method recommended in the instructions for use.
KARLSTORZGermany
Storzand Bickel
In April 2021, the FDA communicated about reported patient infections and possible contamination issues with reprocessed urological endoscopes. At the FDA’s request, Karl Storz conducted reprocessing validation testing on a sample of flexible urological endoscopes and identified reprocessing failures following high-level disinfection. Inadequate reprocessing of urological endoscopes may increase the risk of patient infection.
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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.
KARLSTORZendoscopy
STORZMEDICAL
The FDA will continue to keep health care providers and the public informed if new or additional information becomes available.
The FDA will continue to work with Karl Storz to evaluate the root cause of reprocessing failures, and to ensure that an adequate supply of urological endoscopes are available for users and patient care.
The FDA recommendations from the April 2021 letter to health care providers have not changed for reprocessed urological endoscopes by other manufacturers.
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Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
The FDA wants to ensure that health care providers and users are aware of the change in reprocessing methods for certain urological endoscopes by Karl Storz. The FDA will continue to monitor reports of patient infections or contamination issues with urological endoscopes, and work with manufacturers on adequate reprocessing methods and instructions.
KARLSTORZ
The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with reprocessed urological endoscope devices.
Since 2017, the FDA has evaluated medical device reports that describe patient infections post-procedure or other possible contamination issues associated with reprocessed urological endoscopes. There are multiple possible root causes for these issues, including inadequate reprocessing or maintenance issues (for example, device failed leak testing), reprocessing instructions in the labeling (including cleaning of accessory components), and device design (including specific device components). Based on the available data, we continue to believe the risk of infection is low. However, health care providers and users should be aware that patient infections associated with reprocessed urological endoscopes can and do occur.
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As the U.S. Food and Drug Administration (FDA) continues to evaluate the risk of patient infections and contamination issues associated with reprocessed urological endoscopes, the FDA is aware that the current reprocessing instructions for certain urological endoscopes manufactured by Karl Storz are inadequate and are being changed updated by Karl Storz. The affected urological endoscopes include cystoscopes, ureteroscopes, cystourethroscopes and ureterorenoscopes, used for viewing and accessing the urinary tract.