If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional narrative: udi: (b)(4).Investigation summary: the device was received and evaluated at the service center.The reported complaint that the vapr vue wireless footswitch would not pair with the generator was confirmed.This was due to the defective transmitter pcb, and replacement of the transmitter pcb would correct the reported complaint.However, there were broken inserts on the housing of the unit, and repair would require replacement of the housing.Since the housing cannot be replaced this unit was deemed unrepairable and was placed into long-term hold.The broken inserts on the housing are most likely a result of user mishandling of the device or a possible fall.The faulty parts was identified as the root cause for the device pairing failure during the service evaluation.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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.
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It was reported by the sales rep that during a quality check on (b)(6) 2021, it was observed that the footswitch device would not pair with the generator device.During in-house engineering evaluation, it was determined that there were broken inserts on the housing of the device.There was no procedure nor patient involvement reported.No additional information was provided.
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