(b)(4).One used lf5544 was received for evaluation.Visual inspection found the clear insulation was missing from the device.The insulation piece was not returned.The customer reported that the plastic on end of device cracked during procedure.The reported condition was confirmed.The sample failed hipot testing.The investigation identified the root cause of the investigation findings to be user error.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 the insulation.
|