It was reported that during a chole procedure the surgeon expressed that her bovie wasn¿t working, she felt like she was not was getting enough power, coag effect, so power level was adjusted from 3 to 5, and then hemostasis was acceptable remainder of case.All was working well at power level 5 without bleeding issues.Arching events with monopolar.Switched mega soft pad to sticky pad and that resolved the issue.Viodv generator for robotic procedures were used.There was a pink pad between the megasoft and the patient.The case was completed with no patient consequences.
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(b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.The device history records were reviewed and certed by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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