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: loop broken.Probable root cause: user excessive force or torque.Manufacturing/assembly error.Severe shipping conditions.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.Lot number is unknown; therefore, manufacture date can not be confirmed.(b)(4).
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