Catalog Number DYNJ35686B |
Device Problem
Sparking (2595)
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Patient Problem
Superficial (First Degree) Burn (2685)
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Event Date 06/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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It was reported that during a plastics procedure, the cautery device sparked and the patient experienced a 1st degree burn to an unidentified location.No medical intervention or follow-up care was reported to the manufacturer.No impact to the procedure was reported to the manufacturer.A sample was returned to manufacturer for evaluation.Sample investigation is ongoing at this time.Due to the reported spark and 1st degree burn, this medwatch is being filed.If and/or when additional relevant information becomes available, a supplemental medwatch will be filed.
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Event Description
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It was reported that during a plastics procedure, the cautery device sparked and the patient experienced a 1st degree burn.
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Manufacturer Narrative
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The manufacturer completed the investigation of the returned sample.According to the reporting facility, it was believed that blood was entering the cautery device and that this caused the reported spark.Inspection of the cautery device identified blood on the indent of the device.When the cautery device casing was opened, no blood ingress was identified within the body.The blood was present only to the surface of the casing and it is highly unlikely that the reported spark originated from the cautery device.A root cause for the reported incident could not be determined.If additional relevant information becomes available another supplemental medwatch will be filed.
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Search Alerts/Recalls
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