Model Number RS271A30 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Burn(s) (1757)
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Event Date 10/31/2023 |
Event Type
Injury
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Manufacturer Narrative
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As neither a lot number nor involved samples have been made available to the date of this report no investigation could be performed so far.Currently no conclusion can be drawn what might have caused the incident.However we will repeat requesting further information and the involved sample and will relay any in a follow up report.
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Event Description
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On (b)(6), 2023 we have been informed about an incident involving a dispersive electrode.A tilf procedure was performed at (b)(6) hospital in the us.A megadyne dispersive electrode catalog number 0855c (our model rs271a30) and an unkown generator had been used.The initial report was stating that "sales rep reported electrode alarm error occurred multiple times on efu during a tilf procedure.Or staff checked device to confirm placement of 0855c.At the end when surgical drapes were removed, small burn was discovered 2-3 millimeters right above patients crevice of patients buttocks.The staff covered the small burn with steri strip.After noticing burn, staff checked drapes for burn/hole and none were discovered." no further information was provided on the body type/weight of the patient, whether the placement site was prepped, the precise position and orientation of the dispersive electrode relative to the surgical area, the duration of the procedure and the activation cycle despite repeated requests.
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Manufacturer Narrative
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As neither a lot number nor involved samples have been made available to the date of this report no investigation could be performed so far.After repeated requests for further information and samples for testing we have been informed on december 11th, 2023 that: "at this date no information has been provided, this file will be close[d] (.)" no conclusion can be drawn what might have caused the incident.We therefore close the investigation and the report.
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Event Description
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On (b)(6) 2023 we have been informed about an incident involving a dispersive electrode.A tilf procedure was performed at uchealth poudre valley hospital in the us.A megadyne dispersive electrode catalog number 0855c (our model rs271a30) and an unkown generator had been used.The initial report was stating that "sales rep reported electrode alarm error occurred multiple times on efu during a tilf procedure.Or staff checked device to confirm placement of 0855c.At the end when surgical drapes were removed, small burn was discovered 2-3 millimeters right above patients crevice of patients buttocks.The staff covered the small burn with steri strip.After noticing burn, staff checked drapes for burn/hole and none were discovered." no further information was provided on the body type/weight of the patient, whether the placement site was prepped, the precise position and orientation of the dispersive electrode relative to the surgical area, the duration of the procedure and the activation cycle despite repeated requests.
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Search Alerts/Recalls
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