Catalog Number 05.001.201 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/09/2018 |
Event Type
malfunction
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Manufacturer Narrative
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This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to improper maintenance.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Event Description
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It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the motor device overheated.There were no delays in the surgical procedure.A spare device was used to complete the procedure.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Manufacturer Narrative
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Upon further review of the device evaluation, a review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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