Qn#(b)(4).Customer complaint cannot be confirmed based on the following: the unit was received with the tip released, but the punch could not be actuated, it was jammed.The punch was disassembled, and residues (tissue) were found in core, after cleaned it no jammed issue were observed, the punch moved freely.The ifu specify "remove the excised tissue before additional openings are created".It is unknown if this step was performed during use.During functional test (with the core cleaned) no issues were found.The punch makes circular cuts without jammed issues.Additionally, all dimensional testing was withing current specs.A device history record review was performed, and no relevant findings were identified.Also, the customer description indicates that the device was used on the artery.However, it does not specify in which one, since this device only can be use in the aorta.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a corrected data: n/a.
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