Investigation: x- no sample returned x-review dhr.Analysis and findings: it has been approximately 55 days and the reported sample has not been returned for investigative analysis.This product is purchased from, pouched and sterilized by a supplier.Packaging for shipping is performed at coopersurgical.A review of two year incoming inspection records does not show any non-conformities (part number 395-310a).A review of two year complaint history does not show any complaints.The lot number reported was 038408, however, pictures with the complaint show lot number 038411.All finished goods inventory are depleted for both lot numbers.A review of dhr's (177193, 177194, 178622, 214563, 214564, 225249) using the two reported lot numbers did not show any abnormalities.According to the complaint, this product was not used with a cooper recommended dual return pad.Although the root cause cannot be reliably determined, it is possible the user may have created an alternative path for grounding by leaning on the patient's skin.Correction and/or corrective action / *preventative action activity none at this time.Will continue to monitor for trending.
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