(b)(4) the dhr for the returned device 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 april of 2020.Evaluation of the returned instrument shows that the tips are loose and misaligned, and the jaw pivot pin is pulled thru one side of the damaged/bent outer tube assembly.We are able to validate this complaint.We are unable to determine what caused the jaws to be loose and misaligned and for the jaw pivot pin to be pulled thru one side of the bent/damaged outer tube assembly 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.
|