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Catalog Number 530.610 |
Device Problems
Mechanical Problem (1384); Device Inoperable (1663)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Additional narrative: this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and observed that the motor seized and running rough.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to strain/wear from normal use and servicing.If additional information should become available, a supplemental medwatch report will be sent 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 seized and was running rough on the battery oscillator device.It was noted that the motor had a dead point which caused the device to stop suddenly.It was noted in the service order that the device handpiece worked in one moment, and then was completely dead.It was further noted that something was wrong with the trigger on the device.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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