The reported smartstitch pp connector, intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Without the reported product a visual and functional evaluation cannot be performed and customers complaint cannot be confirmed.From the information provided, the top jaw of the device broke off in the patient when it was removed from the cannula.The broken piece was removed.An exact root cause cannot be determined without evaluation of the device; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: excessive force.Excessive force can result in damage to the device.The instruction for use (ifu) were reviewed and were 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 that would suggest that the device did not meet product specifications upon release into distribution.
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