This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation.Please see updated sections: d8, g3, g6, h2, h6 and h10.The legal manufacturer performed an investigation.The root cause of the issue could not be conclusively specified.The probable cause of the event was most likely due to user mishandling.The instruction for use (ifu) states the following guidelines: "study this manual and other labeling thoroughly for safe handling and storage.Misuse of instruments can cause injury to the patient and could have an adverse effect on the procedure being performed.Do not drop instruments or allow them to be struck by other objects." in addition, corrosion is often incurred as a result of chemical stress and inappropriate storage environment.Section 5.0 (maintenance) and section 6.0 (storage) of the device ifu provides instructions regarding agents/solution and methods for appropriate cleaning, sterilization and storage of the device.Ifu alerts ¿use of any procedures not expressly recommended by gyrus acmi may adversely affect or damage gyrus acmi devices.¿ corrected data: please see updated section: d9.
|