Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The instrument was received partially applied with twelve remaining clips.A scissored clip was received.Functionally, the instrument was fired once in air and proper clip formation was confirmed.The remaining clips were then fired on test media with proper formation.The jaw and handle moved smoothly through the firing cycle and returned to the open position and each remaining clip loaded properly in the jaw.When the cartridge was empty, the interlock engaged and prevented the jaw from approximating.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the scissored clip condition may occur if the distal end of the device is subjected to excessive manipulation during application of the instrument.The root cause of the observed damage was due to the product not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.
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