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Model Number MAJ-2111 |
Device Problem
Fracture (1260)
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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 not returned.The investigation is ongoing and should additional relevant information become available, a supplemental report will be submitted.This report is related to linked patient identifier: (b)(6).
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Event Description
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It was reported, the connecting tube tubesets had broken connector tabs.The issue was observed during reprocessing.There were no reports of patient harm.
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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.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, external stress was applied to lock lever of the connecting tube, which led to breakage of the tube.The cause of the external stress on the lock lever was not established.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu) which states the following: ¿visually inspect the connecting tube to ensure that there are no cracks, breaks, rips, scratches, attached debris, or other irregularities.Move the lock levers of the reprocessor side connector to make sure that they function properly and are not broken.¿ olympus will continue to monitor field performance for this device.
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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 updated investigation and device evaluation.Additionally, to provide a correction to the initial with information inadvertently left out (d8) and to provide an update to fields (d9, h3, and h6).The device was evaluated by olympus.And it was confirmed, that one of the locking levers broke off and was not returned with the devices.Based on the results of the updated investigation, it is likely, that the external stress occurred, due to the user may have applied stress toward wrong direction.Which, caused the external stress.However, a specific root cause of the reported problem could not be identified.
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Search Alerts/Recalls
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