The reported perfectpasser connectors, intended for use in treatment, were returned for evaluation.A relationship between the devices and reported incident was established.From the information provided, jaws disengaged from the device.Visual inspection shows the connectors were received with the s-clamp unhooked from the s-hook.One of the connectors was returned without the s-clamp.Internal investigation indicates the failure cause for upper s-clamp coming loose is due to a dimensional discrepancy on the s-hook component.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
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