Catalog Number 7126120000 |
Device Problems
Overheating of Device (1437); Biocompatibility (2886)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/01/2016 |
Event Type
malfunction
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Manufacturer Narrative
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This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).Two device evaluations are in progress.There were no remedial actions taken.This device is not labeled for single-use.
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Event Description
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This report summarizes 2 malfunction events in which the device overheated and had a condition in which the non-sterile battery had the potential to be exposed to the surgical site.Two reported event had patient involvement; no patient impact.
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Manufacturer Narrative
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This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).Corrected data: 2 devices were expected to be received; however, the devices were not available for evaluation.There were no remedial actions taken.This device is not labeled for single-use.Device not returned.
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Event Description
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This report summarizes 2 malfunction events in which the device overheated and had a condition in which the non-sterile battery had the potential to be exposed to the surgical site.Two reported event had patient involvement; no patient impact.
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Search Alerts/Recalls
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