Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation: the device was not returned and there were no photos of the complaint product were provided.There were no additional product sets remaining of the same lot consequently a physical product investigation could not be carried out.A review of complaint history, the device history record, quality control data, and specifications was performed.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history revealed one other complaint associated with lot number 8211194.The second complaint was from the same facility and for the same failure mode.A document review did not identify any anomalies with the manufacturing process or any non-conformances.The tubing used for the stent is supplied with tensile test data that indicated it met specification.Raw material incoming inspection also carried out tensile testing on the same material.The data was reviewed for the complaint lot and found to meet specification.Based on the provided information a definitive cause of the alleged complaint issue cannot be determined.Measures have been initiated to address the reported failure mode.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation: the device was not returned and there were no photos of the complaint product were provided.There were no additional product sets remaining of the same lot consequently a physical product investigation could not be carried out.A review of complaint history, the device history record, quality control data, and specifications was performed.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history revealed one other complaint associated with lot number 8211194.The second complaint was from the same facility and for the same failure mode.A document review did not identify any anomalies with the manufacturing process or any non-conformances.The tubing used for the stent is supplied with tensile test data that indicated it met specification.Raw material incoming inspection also carried out tensile testing on the same material.The data was reviewed for the complaint lot and found to meet specification.Based on the provided information a definitive cause of the alleged complaint issue cannot be determined.Measures have been initiated to address the reported failure mode.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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