Model Number MAJ-891 |
Device Problems
Break (1069); Degraded (1153)
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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 subject device was not returned to omsc for evaluation but was returned to olympus europa (b)(4).Olympus europa (b)(4) checked the subject device and found the reported phenomena.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.
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Event Description
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Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at olympus europa (b)(4), it was found that the lever with the stopper was detached from the subject device, and there was corrosion on the tightening ring.The date of event is unknown.There was no report of patient injury associated with the event.
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Manufacturer Narrative
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This supplemental report is being submitted to provide the subject device evaluation result.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation but was returned to olympus europa se & co.Kg (oekg).Omsc could not review the manufacturing history record (dhr) because the lot number was unknown, but normally, products that meet the shipping standards are shipped from the factory.Based upon the information from oekg, omsc considered that the reported phenomena were attributed to the followings.- the lever with the stopper was detached from the subject device; a) the strong chemical stress was applied to the subject device.B) the strong physical stress was applied due to such as forcibly attaching and detaching parts.The deterioration of the glue due to the combination chemical stress during reprocessing such as a) and b) and the mechanical stress during assembly.- there was corrosion on the tightening ring; the occurrence of crevice corrosion, the glue that fixed the tightening ring was corroded and discolored.
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Search Alerts/Recalls
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