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Model Number MAF-DM2 |
Device Problem
Peeled/Delaminated (1454)
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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 evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was observed that during the device evaluation, the airway mobilescope exhibited insertion site, flexible tube, coating peeled.There was no patient involvement.
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Manufacturer Narrative
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This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: e1 (establishment name).A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 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 like that the event reported as "insertion section tube coating peeled off" was caused by a stress of repeated use, external factors or handing.The event can be detected/prevented by following the instructions for use which state: there is a warning in the instruction manual ¿chapter 3 preparation and inspection 3.6 inspection of the endoscope." olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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