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Catalog Number QD8 |
Device Problems
Metal Shedding Debris (1804); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/02/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Additional narrative: (b)(4).(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 to improper maintenance, which is user error/misuse/abuse.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 attachment device had a lot of debris and blood in the mechanics.It was noted that there were foreign debris: metal shavings.It was also noted that the device failed pre-repair diagnostic tests for thimble set screw and temperature assessment.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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