The device was returned for analysis.The reported material deformation and shaft stretching were 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 from this lot.The investigation cannot determine a conclusive cause for the reported material deformation; however, factors that could contribute to material deformation include, but are not limited to, interaction with accessory devices, interaction with difficult anatomy and product damage during handling by user.The reported shaft stretching appears to be related to operational context as it is likely handling and/or manipulation of the device during the procedure caused the reported shaft stretching.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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