FDA-Device2023-08-16Class II
UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a cystoscope shaft into the bladder. Model: UL-VO
Scholly Fiberoptic Gmbh
Hazard
There is an improperly performed weld between the cone of the sheath lock and tube of the obturator; mechanical load capacity is impaired, and fracture of the welded joint may occur. Contamination can occur in this capillary gap, which is not covered by the reprocessing validations performed.
Sold states
Nationwide Foreign: Japan, South Korea
Affected count
98 units
Manufactured in
Robert-Bosch-Str. 1-3, N/A, Denzlingen, N/A, Germany
Products
UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a cystoscope shaft into the bladder. Model: UL-VO
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2364-2023Don't want to check this manually?
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