Catalog Number 0703047000 |
Device Problems
Unintended Power Up (1162); Excessive Heating (4030)
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Patient Problem
Superficial (First Degree) Burn (2685)
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Event Date 09/05/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H6: a follow up report will be filed once the quality investigation is complete.H3 other text : device not available for return.
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Event Description
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Per medwatch report (b)(4): it was reported that during a procedure the e-sep pencil rocker switch was sensitive and easily activated.The customer also stated they believed that the electrocautery devices are hotter than the previously used electrocautery devices.The tip of the e-sep pencil burned the patient on the right upper quadrant of the abdomen.Degree is not documented, skin is deep red in appearance, no size of injury documented.An antibiotic ointment was applied to the area.The wound may potentially scar but it is not likely to need additional/continuing treatment.No infection was reported.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
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Manufacturer Narrative
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Correction d9/h3: device not available for return.H6: the quality investigation is complete.H3 other text: device not available for return.
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Event Description
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Per medwatch report (b)(4): it was reported that during a procedure the e-sep pencil rocker switch was sensitive and easily activated.The customer also stated they believed that the electrocautery devices are hotter than the previously used electrocautery devices.The tip of the e-sep pencil burned the patient on the right upper quadrant of the abdomen.Degree is not documented, skin is deep red in appearance, no size of injury documented.An antibiotic ointment was applied to the area.The wound may potentially scar but it is not likely to need additional/continuing treatment.No infection was reported.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
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Search Alerts/Recalls
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