This report is for the 2nd of 3 procedures linked to mfg report numbers 3006697299-2021-00030 and 3006697299-2021-00032: a facility reported that during three tumor removal procedures, the surgeon experienced low amplitude issues with the cusa excel w/ console (cusaexcel9), and stated that the device did not work properly in fragmenting.The procedure was completed with 'tumor removed with bipolar', and the surgery time was increased by only 15 minutes.No patient injury was alleged.
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Updated fields: d9, g3, g6, h2, h10.Additional information and clarification received from customer as follows: only two events occurred on (b)(6) 2021, and not three as initially reported.Only one surgery, one patient impacted on (b)(6) and two consoles failed with low amplitude during the same surgery, not three as initially indicated.First console was set up and failed, then accordingly, another console was taken and also failed.
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