The product was not returned for investigation therefore the reported failure mode was not confirmed.
The failure mode will be monitored for future reoccurrence.
Alleged failure: wire broke.
Probable root cause: user excessive force or torque, user error in not properly inspecting unit prior to use, material/design error, constant irrigation flow is not maintained leading to limited field of view, low lubricity of insulation for fulgurating electrodes, incompatible instrumentation used with electrode.
Manufacture date is not known.
(b)(4).
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