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Catalog Number 05.001.202 |
Device Problems
Crack (1135); Overheating of Device (1437); Incorrect Or Inadequate Test Results (2456)
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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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(b)(4).This 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 duplicated and confirmed.The assignable root cause was determined to be due to improper miantenance, which is user error/misuse/abuse.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 in the service order from (b)(6) that the power module device was overheating.During service and evaluation, it was observed that the device housing was cracked.It was further determined that the device failed the general condition and lever pre-test.This event did not occur during surgery.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.There was no patient involvement reported.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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