Model Number GIF-H290 |
Device Problems
Partial Blockage (1065); Particulates (1451)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The device was returned to an olympus repair facility, and an evaluation of the device was performed.During the evaluation, foreign material was discovered lodged in the nozzle of the device.The customer's originally reported issue of weak water supply/intake was also confirmed.Additionally, the following additional findings were noted: insufficient air supply; nozzle drainage failure; a-rubber adhesion chip; a-rubber adhesion cracks; a-rubber adhesion cloudiness ; c-cover scratches.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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Event Description
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The customer reported that there was a weak supply of water/intake when using their evis lucera elite gastrointestinal videoscope.Upon inspection and testing of the returned unit, foreign material was found to have been lodged in the device nozzle.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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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.The foreign material was unable to be identified.It was confirmed that there was no deformation of the air/water nozzle.It was unclear whether the reprocessing was performed according to the instructions for use (ifu).The inspection method for the event is described as follows in the ifu "chapter 3 preparation and inspection 3.3 inspection of the endoscope and 3.8 inspection of the function in combination with related equipment".[inspection of entire endoscope] 8.Visually check that there are no abnormal protrusions, dents, or deformations in the air/water nozzle at the tip of the endoscope.[inspection of objective lens surface cleaning function] ¿when using the air/water button 1.Cover the air/water button hole with your finger.2.Push the button while covering the hole.Ensure that water flows across the endoscopic image." olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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