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Model Number LTF-S190-5 |
Device Problem
Contamination /Decontamination Problem (2895)
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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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A user facility submitted a repair request to the olympus service center, for an endoeye flex deflectable videoscope for having missing curved rubber adhesive.Upon inspection and testing of the customer returned device, foreign material was found objective lens, illumination lens, angle rubber and insertion pipe.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.There was no report of patient harm or user injury associated with this event.
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Manufacturer Narrative
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The customer suspected device was returned for investigation.The olympus service center confirmed the reported event during inspection and testing.Upon evaluation of the returned device the following defects were found, foreign object on the tip metal part, curved rubber adhesive missing, foreign object in the objective lens, foreign object in the lighting lens, foreign matter found in the hard tube, foreign matter found on the curved rubber, scratches found on the operation part, scratches found on the grip, video connector cracked, scratches found on the video connector, scratches found on the light guide connector, scratches on the light guide cover glass surface, and scratches found on the video connector case.The faulty parts were replaced, and the device was returned to the user facility.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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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 to the distal end, the objective lens, lighting lens, the bending section cover, or insertion pipe.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".[inspection of the entire endoscope] confirm that there are no scratches, chips, dirt, gaps around the lens, or other abnormalities on the tip of the lens.Visually check that there are no cracks, dents, edges, scratches, or other abnormalities on the appearance of the insertion tube.(see figure 3.2).Visually confirm that there are no abnormal slacks, bulges, dents, scratches, holes, or metal wires protruding from the inside of the covering material of the curved part.(see figure 3.2).Check that there are no scratches, chips, or cracks in the adhesive on both ends of the bend covering." olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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