(b)(4).The product was returned and the failure mode was confirmed.Visual inspection: cracked insulation observed.Ifu states: "before use, ensure that there are no breaks, chips, cracks, scratches, tears, or missing/loose components on the shaft insulation, handle, or housing.Do not use the instrument if any of these defects are present as this could cause unintended electrosurgical burns and life threatening complications.If damage has occurred, discontinue use and return the instrument for repair or replacement." functional inspection: the insulation was tested with an insulscan device.The insulation failed the insulscan test.The probable root causes for the reported failure involving this device could be due to improper sterilization methods, rapid cooling after sterilization, contact with metal tray during sterilization, or 4) normal wear and tear.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.
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