510 (k) number: k083330.(b)(4).Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on 07 nov 2018.The needle was found to be broken proximal to the sheath extender.Document review: prior to distribution, all echo-19 devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.Ifu review: the notes section of the instructions for use, ifu0101-0, which accompanies this device instructs the user to inspect the device prior to use for any damage: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".There is no evidence to suggest that the customer did not follow the instructions for use (ifu0101-0).Root cause review: a definitive root cause for the customer complaint could not be determined as circumstances of use cannot be replicated in the laboratory.A possible cause could be attributed to device handling or excessive force being applied causing the needle breakage when attaching or detaching the device to the scope.Summary: complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
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