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Catalog Number EMAX2PLUS |
Device Problems
Break (1069); Material Discolored (1170); 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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Initial reporter's phone number: (b)(6).The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due user error, abuse, and/or misuse.If additional information should become available, a supplemental medwatch report will be submitted.
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Event Description
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It was reported by the (b)(6) that during service and evaluation, it was observed that the cable/cord/wiring was damaged on the motor device.It was further noted that the motor flex, motor and safety lock were defective, and the hose was stained strongly.It was noted that the pin was missing from position 35.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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