Model Number MAJ-2110 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/13/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device has not been returned to olympus for evaluation.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
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Event Description
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The customer reported to olympus technical assistance center (tac), during reprocessing, the connecting tube was damaged.There was no harm or user injury reported due to the event.The serial number of the subject device is not provided at this time.This report is related to similar events.(patient identifier : (b)(6).
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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 was not returned; therefore, the reported phenomenon or condition of the device could not be confirmed.The device history record (dhr) was unable to be reviewed for this device.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.It has been over 1 year since the subject device was manufactured.The specific root cause of the reported problem could not be determined at this time because the device was not returned.However, it is probable that the connecting tube could not be connected due to the coming apart of the lock lever by external stress.The following information is stated in the instructions for use (ifu): ¿9 preparation and inspection 3 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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Search Alerts/Recalls
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