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Catalog Number EMAX2PLUS |
Device Problems
Component Missing (2306); Device-Device Incompatibility (2919)
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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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Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to user error.Udi:(b)(4).
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Event Description
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It was reported that the motor device cutters could not be inserted and was missing the protective washing cap.During an in-house engineering evaluation, it was determined that the device ran in the locked position - power broken, had missing components and cable damage.It was further determined that the device failed pre-test for cable and safety.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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