(b)(4).The sample was returned and sent to the manufacturer for evaluation.The manufacturer reports they performed an inspection on the handle head to confirm the width, which may contribute to tight issues with the blade; however, the width of the handle head was within specification.Heavy damages were observed near the slot area on the handle head due to the second ball bearing of the blade which had a damaged surface resulting in the tight issue with the blade and handle.A device history record review was performed and no relevant findings were identified.The manufacturer also reports that from a dimensional inspection, the product was conforming to the design specification.The slot on the head of the handle was found damaged which could be due to damage of the ball on the blade used for engagement.The handle was tested with a teleflex laryngoscope and was working fine.The root cause of the issue was determined to be user related.
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