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Recall Observatory FDA recall evidence

Device product

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

Z-2364-2023

June 23, 2023

Class II

Product summary

Firm
Scholly Fiberoptic Gmbh
Event
Event 92700
Status
Ongoing
Classification
Class II
Quantity
98 units
Official record key
device-enforcement:Z-2364-2023

Official wording

Reason: 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.

Code information: UDI-DI: 04250480106617 Lot Number: 141980

Distribution pattern: Nationwide Foreign: Japan, South Korea

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.