H10: h3, h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A visual inspection observed the footswitch port is pushed inside the unit and the lid and bezel are damaged.A functional evaluation revealed most settings cannot be tested due to the footpedal port being pushed inside the unit.The unit was opened and found the footpedal port and its hardware loose inside the unit.The complaint was verified.Factors, unrelated to the design or manufacture of the device which could have contributed to the complaint event, include misalignment of the connector when connecting to the unit receptacle in which excessive force or twisting could cause damage.No containment or corrective actions are recommended at this time.There are no indications to suggest that the device/product did not meet specifications upon release into distribution.
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