Endoscope models recalled for image loss during electrocautery activation
Karl Storz endoscope models may lose image when monopolar electrocautery is activated. The recall affects 401 units distributed to hospitals in 33 U.S. states and Canada.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a functional failure during active medical use. No adverse events are reported in the source material. The loss of image during electrocautery represents a risk-of-harm scenario where injury has not yet been reported, consistent with the High severity criterion.
Plain-English summary
Karl Storz Endoscopy is recalling multiple models of CMOS Video Cysto-Urethroscope endoscopes. The affected models are REF 11272VUE, 11272VUEK, 11272VUE-R, and 11272VUEK-R. A total of 401 units were distributed worldwide, including to hospitals and surgical centers in 33 U.S. states and Canada.
The endoscopes may experience a loss of image when monopolar electrocautery is activated during surgical procedures. This problem is caused by a manufacturing assembly process defect affecting specific units identified by serial number.
Hospitals and surgical centers using these devices should immediately verify whether they have units matching the recalled serial numbers. Affected facilities should contact Karl Storz Endoscopy for instructions on the next steps, which may include repair, replacement, or return of the affected devices. Do not use affected units until the defect has been resolved.
The recalled product
- Product
- STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS Video Cysto-Urethroscope C-VIEW KIT REF 11272VUE-R CMOS Video Cysto-Urethroscope REF 11272VUEK-R CMOS Video Cysto-Urethroscope C-VIEW KIT
- Manufacturer
- Karl Storz Endoscopy
- Affected units
- 401
Distribution
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