Other, other text: h3.Device evaluated by manufacturer and h6.Health impact, event problem and evaluation codes: updated.One used set of tracheostomy components were received for investigation.The reported issue was confirmed during visual inspection when the guidewire was observed to be bent and the wire cut.During the manufacturing process this product is 100% inspected for guidewire condition before release, and the observed condition would have caused the device to be rejected.A review of manufacturing device history records found no observations recorded during manufacturing to suggest an issue of this nature would occur with this lot of product.The investigation attributed the root cause of the observed condition of the guidewire to damage that occurred while the product was in use.As no manufacturing related root cause was found, no actions have been taken at this time.
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