The 25 gauge illuminated flex curved laser probe was received and a visual assessment of the returned sample revealed significant adhesive on the cannula tip.The 25 gauge illuminated flex curved laser probe was inserted into a 25g trocar.The sample had resistance when inserted into the 25g trocar, confirming the reported event.Additionally, the sample¿s cannula outer diameter (od) was measured.With an od min/max values of 0.0200 to 0.0205 inches, the sample¿s cannula od was measured to be 0.02025 to 0.02035, meeting specifications.Based on qa assessment, the 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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