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Model Number BF-260 |
Device Problems
Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)
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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 the sheath from the introduction sheath to the distal end of the evis lucera bronchovideoscope was worn.There was no reported patient harm or impact due to this event.During device evaluation at olympus, it was found the bending section cover came off and the coating of the connecting tube was peeled.The report is being submitted due to the defects found during evaluation.
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Manufacturer Narrative
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Attempts to retrieve additional information from the customer are in progress.The device was returned and evaluated by olympus.In addition to the findings in b5, evaluation found the leak test and electrical safety test failed due to missing bending section cover, the light guide cover lens was broken, the scope cover was damaged, the connecting tube was dented, the universal cord was buckled and scratched, the connector was corroded, the electrical connector was corroded, angulation was reduced and the suction failed due to the missing bending section cover.This event is under investigation.A supplemental report will be submitted upon receiving additional information.
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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 device history record and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issue were identified.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, it is likely that physical stress was applied to the insertion section, causing the coating to peel.However, a definitive root cause could not be determined.The following information is stated in the instructions for use (ifu): ¿3.2 inspection of the endoscope 5.Inspect the external surface of the entire insertion tube including the bending section and the distal end for dents, bulges, swelling, peeling, scratching, holes, sagging, transformation, bends, adhesion of foreign body, dropout of parts, any protruding objects or other irregularities.¿ olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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