Unit not returned for eval; updated mdr flowchart completed; this lot has a (b)(4) complaint rate; dhr review does not indicate a mfg error; three complaints from this facility in three months- uncertain of number of cases performed, may be a training issues; without an eval there is no determination of malfunction cause - refer to capa (b)(4) initiated october 2012 to investigated the numerous stopped working issues (b)(4).A was released with results for the verification effectiveness of a larger electrode bend radius of the microtip; the increased electrode bend radius indicated improved output of the manufacturing process and elimination of failures due to electrode breakage.
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