(b)(4).The clear insulation had rolled up on the device.The device failed hipot testing.The ifu states to prevent damage to the flexible insulation proximal to the jaws, confirm the handle is fully closed prior to insertion into and extraction from the cannula.Use the appropriately sized cannula to allow for easy insertion and extraction of the instrument.Failure to do so may impact the integrity of the flexible insulation.Cannulas with hard, non-beveled openings may cause the flexible insulation to retract, which may compromise the insulation.If retraction occurs, the instrument must be discarded.Do not attempt to clean the flexible insulation.Cleaning may damage insulation.The knife did not advance when the trigger was activated and it was found that the knife was hitting the back of the blue jaw seal plate.This can happen when the user places excessive tension on the jaws, forcing them out of alignment.The ifu cautions the user to not turn the rotation wheel when the handle is fully closed and latched.Product damage may occur.Do not apply force to the shaft of the instrument causing tension or bowing as this could make the knife difficult to deploy and the trigger may not return to its normal position.When the knife contacted the back of the seal plate, the trigger was forced and this caused the webbing to protrude.One was sharp and the other was not sharp.The ifu states to gently pull the cutting trigger to engage the cutting mechanism.
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