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‘Numerous’ Adverse Event Reports Of Infections Spark FDA Warning For Urological Endoscopes

Olympus, Karl Storz called out by FDA; agency says risk to patients is low

 
• By Shawn M. Schmitt

The US FDA says it has received more than 450 Medical Device Reports since 2017 that describe patient infections following use of reprocessed cystoscopes, ureteroscopes and cystourethroscopes. Three deaths were reported by Olympus Corp.

Fiberoptic Ureteroscope Using For Urological Procedures.
The FDA is warning about urological endoscopes, including ureteroscopes

The US Food and Drug Administration on 1 April sounded the alarm over recent adverse event reports that indicate patient infections linked to reprocessed urological endoscopes, including cystoscopes, ureteroscopes and cystourethroscopes.

The scopes are used by health care providers to view and access a patient’s urinary tract.

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