It was reported by the customer, in the middle of an upper endoscopic ultrasound (eus) procedure, the buttons were sticking on the evis exera ii ultrasound gastrovideoscope and the narrow band imaging (nbi) light was coming on without hitting the button.The intended procedure was completed with the same device and no surgical delay.No other device was involved in the event.No patient harm reported.The device was inspected prior to use and was working fine.During the evaluation of the device, it was noted the forceps cover glue was peeling.This report is to capture the reportable malfunction of the peeling forceps cover glue noted at estimation.
|
This report is being supplemented to provide additional information based on the legal manufacturer's 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 3 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, the root cause of the forceps cover glue peeling could not be identified.However, it is possible the cause was related to external force that was applied to the tip.The instructions for use identify the following verbiage, that may prevent the phenomenon: do not apply shock to the distal end of the insertion section, particularly the ultrasound transducer and the objective lens, surface at the distal end.Visual abnormalities may result.Olympus will continue to monitor field performance for this device.
|