Additional/corrected: the returned accu-pass device was received with its needle broken near the distal end of the outer tube.Blue cobraid magnumwire was received captured by the needle.Needle and outer tube crimp was present.Per information provided, the tip of the accupass broke off when the surgeon was pushing the instrument through tissue.Based on our visual evaluation, the complaint was confirmed as the needle was received broken.An exact root cause could not be determined with confidence.A potential factor unrelated to the manufacture or design of the device that could have contributed to the reported event includes tissue thickness.Tissue thickness may affect suture placement including stitch depth and needle entry point.The instruction for use (ifu) were reviewed and found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications during manufacturing record review that would suggest the device did not meet product specifications upon release into distribution.
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