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Catalog Number 530.610 |
Device Problems
Vibration (1674); Battery Problem (2885)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/12/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition of the device not oscillating was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was determined that the device emitted an unusual noise.It was further determined that the electric motor was damaged.It was observed that the device had a rough rotation (vibration) and corrosion.It was further determined that the o-rings were damaged and the bearings were worn.The assignable root cause was determined to be due to component wear from normal use over time.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that during pre-surgery, it was discovered that the battery oscillator device would not oscillate.During in-house engineering evaluation, it was observed that the device had a rough rotation (vibration).There were no delays to the surgical procedure as a spare device was available for use.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.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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