Catalog Number 0703047000 |
Device Problems
Unintended Power Up (1162); Excessive Heating (4030)
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Patient Problems
Laceration(s) (1946); Superficial (First Degree) Burn (2685)
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Event Date 09/12/2023 |
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 : awaiting confirmation device is available for return.
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Event Description
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Per medwatch report 1400670000-2023-8004: 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 touched the patients' skin on the right upper abdomen.It was superficial and small.The laceration is not expected result in permanent damage or 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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F10/h6: changed to "laceration".H6: the quality investigation is complete.
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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 touched the patients' skin on the right upper abdomen.It was superficial and small.The laceration is not expected result in permanent damage or 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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