Visual, dimensional and functional inspections were performed on the returned device.The reported difficulty removing the protective sheath was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty removing the protective sheath.However, factors that may contribute to difficulty removing the protective sheath may include, but not limited to, manufacturing, normal variation within the manufacturing process or protective sheath removal technique.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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