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Catalog Number EMAX2PLUS |
Device Problems
Break (1069); Hole In Material (1293); Moisture Damage (1405); Defective Device (2588)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Additional narrative: (b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and observed that there was damaged component - cable/cord/wiring.Therefore, the reported condition was confirmed.It was further determined that the motor and flex were defective (liquid damage), tube was damaged (hole) and the clutch was also damaged.The assignable root cause was determined to be due to not following procedures on cleaning and sterilization, and /or maintenance, which is user error / abuse and possibly misuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Event Description
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It was reported by (b)(6) that during service and evaluation, it was observed that the motor device had damaged component - cable/cord/wiring.It was further determined that the motor and flex were defective (liquid damaged), tube was damaged (hole), and the clutch was also damaged.This event did not occur during surgery.There was no patient involvement.There were no reports of 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 report will be submitted accordingly.
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Search Alerts/Recalls
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