Device was received and evaluated.Evaluation determined that the device was found leaking, the ¿a-rubber¿ was damaged and determined to be a non-olympus including the ¿a-rubber¿ glue unit, and both were noted to be a non ¿olympus unit.In addition, the video connector m-case and plug were found cracked.Minor dent observed on the insertion tube.The device was placed for repair.
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This supplemental report is being submitted to provide review of the device history records (dhr), unique device identifier (udi) number and investigation conclusion.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Based on investigation results, it was confirmed that there was a device repair by third party.As a third party repair was performed on the device, it is not possible to guarantee the safety of the current product as the material used and biocompatibility cannot be confirmed.Repair by third party is prohibited in the instructions for use.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: this instrument does not contain any user-serviceable parts.Do not disassemble, modify, or attempt to repair.Patient or operator injury and/or equipment damage may result.Equipment that has been disassembled, repaired, altered, changed, or modified by persons other than olympus¿ own authorized service personnel is excluded from olympus¿ limited warranty and is not warranted by olympus in any manner.Olympus will continue to monitor complaints for this device.
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