Model Number MAJ-891 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/18/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device in this report has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
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Event Description
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Olympus medical systems corp.(omsc) was informed from the user that during the reprocessing, two subject devices broken.The user facility was reprocessing the subject device as follows, hand wash.Air blow dry.Dryer used for 10 mins on 55 degrees.Neutral chemical.Vpro- max 35min cycle.The user facility did not provide other detailed information.There was no report of patient injury associated with the event.This mdr is the first of two reports.
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Manufacturer Narrative
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The subject device in this report has not been returned to omsc for evaluation.Omsc confirmed the following from information from olympus australia (oaz).At the adhesive part between the resin tightening ring and the stainless steel part inside, the event occurred due to the interface peeling of the adhesive on the tightening ring.Corrosion occurred at the interface between the adhesive and stainless steel parts.Corrosion can be presumed to be crevice corrosion.Crevice corrosion occurs when water enters the interface between stainless steel and resin for a long time.The exact cause of the reported event could not be conclusively determined.However there was the possibility that the reported phenomenon was attributed to the adhesive deteriorated and peeled off due to the combination of chemical stress during reprocessing and mechanical stress which caused by the following factors.
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Manufacturer Narrative
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This supplemental report is being submitted to additional information.In the evaluation of omsc the following was confirmed: a total of 18 maj-891s were returned.It was confirmed that the locking ring was detached in 2 out of 18 devices.The adhesive on the device has interfacial peeling and has turned brown.We checked the application state of adhesive on the actual device with the locking ring detached, but it was applied to all circumferences.Therefore, it is presumed that there was no problem in the adhesive application work at manufacturing.The remaining 16 devices did not come off even if the locking ring was pulled by hand.Although there was a difference in degree, the adhesive that slightly protruded from the main body and the locking ring turned brown.It was also confirmed that the gap between the main body and the metal part turned brown in some devices.In each case, no obvious stain residue could be confirmed.
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Search Alerts/Recalls
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