Additional information provided.Two 25 gauge illuminated flex curved laser probes were received and a visual assessment of the returned samples revealed adhesive on the cannula tips.Each 25 gauge illuminated flex curved laser probe was inserted into a 25g trocar and both became stuck and could not be inserted through the trocar, confirming the reported event.Additionally, the samples¿ cannula outer diameters (od) were measured.With an outer diameter (od) min/max values of 0.0200 to 0.0205 inches, the first sample¿s od was measured to be 0.02030 to 0.02100, not meeting specifications.The second sample¿s od was measured to be 0.025-0.02120, also not meeting specifications.Based on qa assessment, both products met specifications at the time of release.The root cause of the reported event can be attributed to excess adhesive residue on the laser probe tips during manufacturing.An internal investigation has been opened.The manufacturer internal reference number is: (b)(4).
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