(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was produced at the tecomet , inc.Kenosha, wi facility as part of a 50-piece lot in june of 2020.Evaluation of the returned instrument shows that the tips are slightly loose and misaligned in the closed position therefore we are able to validate this complaint.Functional evaluation shows that although the tips are slightly loose and misaligned in the closed position this instrument is able to pick-up, retain, close and release multiple clips both with and without the use of silastic test tubing.We are unable to determine what caused the tips to be slightly loose and misaligned in the closed position but mishandling of this device at the end user's facility is suspected.All 50 instruments from this lot were 100% visually inspected and function tested prior to shipment to the customer as this is a standardized procedure at this facility for this product line.Due to these findings, no further actions will be taken in response to this complaint and this record will be deemed closed.
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