The devices, used in treatment, were not returned for evaluation.A relationship, if any, between the subject devices and the reported event could not be determined since the products were not returned for evaluation.Visual inspection and functional testing could not be performed because the devices in question were not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.If the products associated with this event are returned at a future date, this evaluation will be reopened for investigation.Factors not associated with the manufacture or design of the devices which could result in damage to the tips could be the devices coming into abrupt contact with a hard (metallic) object, improper insertion or removal from an apparatus, or excessive force applied to the tips can also lead to unintended detachment.There were no indications during manufacturing record review that would suggest that the devices did not meet product specifications upon release into distribution.
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