Model Number 36725 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Burn(s) (1757); Septic Shock (2068); Peritonitis (2252); Unspecified Tissue Injury (4559)
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Event Date 10/17/2022 |
Event Type
Injury
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Event Description
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It was reported that a skin burn occurred.A rf3000 radiofrequency generator and a leveen coaccess rf probe were selected for use in a radio frequency ablation procedure.During the procedure, there were no anomalies noted; however, a skin burn occurred.Despite a hydro and carbo dissection with a colon distance of 19mm, there was a colonic wound as well as a burn to the skin 2cm in diameter.The severity of the burn was not assessed.The colonic wound also resulted in septic shock and stercoral peritonitis, which required a left hemicolectomy with colostomy.
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Event Description
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It was reported that a skin burn occurred.A rf3000 radiofrequency generator and a leveen coaccess rf probe were selected for use in a radio frequency ablation procedure.During the procedure, there were no anomalies noted; however, a skin burn occurred.Despite a hydro and carbo dissection with a colon distance of 19mm, there was a colonic wound as well as a burn to the skin 2cm in diameter.The severity of the burn was not assessed.The colonic wound also resulted in septic shock and stercoral peritonitis, which required a left hemicolectomy with colostomy.
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Manufacturer Narrative
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Device eval by manufacturer: the device was returned and analyzed by the external manufacturer, stellartech.No problems were found when the device was analyzed and serviced.Performed power and impedance calibration.Checked and passed stress test.Incrementally powered unit from 0w to 200w at 25 and 100 load.No error occurred.
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Search Alerts/Recalls
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