One opened probe was received, with a tip protector, in a pouch, with the needle stiffener taper to the pouch.The sample was visually inspected and found to be nonconforming with the probe needle/stiffener pulled out of the needle holder and inner cutter bent.The probe was disassembled and the components inspected.No/minimal wear on inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Gouges marks observed at several locations along the inner cutter.A review of the device history record traceable to the reported lot number, indicates that the product was processed and released according to the product¿s acceptance criteria.The complaint evaluation confirms the report of metal part of probe came off handle.The root cause for the component detachment is the adhesive bond failure which caused the needle assembly to detach from the rest of the probe assembly.An internal investigation was completed and improvements to the adhesive bond have been identified.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No further actions are required.The manufacturer internal reference number is:(b)(4).
|