Investigation ¿ evaluation: a review of documentation, drawing, manufacturing instructions, specifications, quality control data, visual inspection and functional testing was conducted during the investigation.A visual examination noted that one of the basket wires had pulled loose from the cannula.The other three wires are secure.A document-based investigation evaluation did not observe any specific issues.Current controls are in place in manufacturing to assure device functionality prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.There is no indication that a design or process related failure mode contributed to this event.Based on the provided information a definitive root cause cannot be established or reported at this time.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
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