Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the device was received and evaluated.Visual inspection reveals that the dome of the mode button is missing.There is severe corrosion on the pedals and foot switch housing.The cable is not tightly secured into the connector strain relief.The device was connected to a vapr vue generator that had an electrode attached to it.The electrode tip was placed in a container of saline solution and the ablate and coag pedals were tested.The device functioned as intended.This complaint cannot be confirmed.There was no evidence that a patient burn could be caused by this foot switch.A manufacturing record evaluation was performed for the finished device lot number on 7-25-2019, and no non-conformances were identified.At this point, as this failure was not confirmed, no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).
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