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Recall Observatory FDA recall evidence

Device product

HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S

Z-0424-2023

November 04, 2022

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 91100
Status
Ongoing
Classification
Class II
Quantity
186 boxes (930 pieces)
Official record key
device-enforcement:Z-0424-2023

Official wording

Reason: An incompatible HF cable may be packaged with the HF Resection Electrodes. This cable cannot be connected to the electrosurgical generator and may lead to delay or cancellation of the surgical procedure.

Code information: Model Number/ UDI-DI/ Lot Number WA22602S 14042761085127 1000090824 WA22603S 14042761085134 1000092201 WA22621S 14042761085172 1000080316 WA22657S 14042761085301 1000092202

Distribution pattern: US Nationwide domestic distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    An incompatible HF cable may be packaged with the HF Resection Electrodes. This cable cannot be connected to the electrosurgical generator and may lead to delay or cancellation of the surgical procedure.