The device was returned to olympus for evaluation and the customer's allegation of ¿no image-unrestorable-error code¿ was not confirmed.The device evaluation found the bending section cover was scratched and adhesive was chipped.Additionally, due to wear of angle the wire, bending angle in up direction did not meet the standard value.Due to damage on the forceps elevator, the bending section could not be fixed firmly.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over (8) eight years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that the problem is caused by damage to the image sensor unit (for example, disconnection) or failure of mounted components (integrated circuit chip, capacitor) on the electrical board due to stress from use, external factors, or handling.The event can be detected/prevented by following the instructions for use which state: 1 before inspection, wipe the objective lens using clean lint-free cloths moistened with saline solution or sterilized water.2 observe the palm of your hand in the wli and nbi endoscopic images.3 confirm that light is output from the endoscope¿s distal end.4 adjust the brightness level as appropriate.5 confirm that the wli and nbi endoscopic images are free from noise, blur, fog, or other irregularities.6 turn the angulation control levers slowly in each direction until it stops.7 confirm that the wli and nbi endoscopic images do not momentarily disappear or display any other irregularities.Olympus will continue to monitor field performance for this device.
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