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Model Number LTF-S190-5 |
Device Problem
No Display/Image (1183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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The customer reported to olympus, the endoeye flex deflectable videoscope had poor image quality when angle was applied.Inspection and testing of the returned device found the image disappears during up/down direction angle operation due to damage to the imaging unit.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
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Manufacturer Narrative
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The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found the following: due to damage on charged coupled device(ccd) unit, a noise image occurred during angulation in up/down (ud) directions, due to damage on the ccd unit, the image disappeared during angulation in ud directions, due to damage on the insertion pipe, insulation resistance value did not meet the standard value, the bending section cover adhesive had a scratch and a chip, switch 1 was damaged, due to damage on the bending tube, bending angle in up direction exceeds the standard value, due to damage on the forceps elevator, 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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Manufacturer Narrative
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This report is being supplemented to provide additional information based on 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.Based on the results of the investigation, the root cause of the event was unable to be identified.It is likely the image sensor unit has been damaged (disconnection, etc.), or the mounted parts (ic chip, capacitor, etc.) of the electric board have failed due to use stress, external factors, or handling.The inspection method for the event is described as follows in the instructions for use (ifu) "chapter 3 preparation and inspection 3.8 checking the function in combination with related equipment"."[inspection of endoscopic images] check if normal light observation images and nbi observation images are displayed normally.1.Wipe the endoscope tip lens with sterile gauze moistened with saline or sterile water before inspection.2.Observe the palm, etc.With normal light observation images and nbi observation images.3.Make sure the light is coming out.(see figure 3.23) 4.Adjust the amount of light to get the proper brightness.5.Check that there are no abnormalities such as noise, blur, or cloudiness in the normal light observation image and the nbi observation image.6.Operate the angle lever of the endoscope to bend the curved part.7.Check that normal light observation images and nbi observation images do not disappear for a moment or other abnormalities." olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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