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Catalog Number 72200616SR |
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 08/28/2017 |
Event Type
malfunction
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Manufacturer Narrative
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No evaluation conducted to date, awaiting receipt of device.
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Event Description
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It was reported that during the procedure, the mdu was overheating.A backup smith & nephew device was available.No injuries or complications were reported.
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Manufacturer Narrative
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The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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Search Alerts/Recalls
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