Product complaint # (b)(4).Is not available for the initial report, a follow-up report will be filed as appropriate.Device analysis: twelve sterile reloads were returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned samples revealed that twelve mic4034 reloads were received with no apparent damage.The packages were opened and the reloads were tested for functionality with a test device for its functionality.Upon functional testing of the clips, the instrument loaded, retained, and deployed clips as intended.The clips were as intended and conform to our manufacturing requirements.As part of quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the clips performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Ten sterile reloads were returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned samples revealed that ten mic4034 reloads were received with no apparent damage.The packages were opened and the reloads were tested for functionality with a test device for its functionality.Upon functional testing of the clips, the instrument loaded, retained, and deployed clips as intended.The clips were as intended and conform to our manufacturing requirements.As part of quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the clips were performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Eighteen sterile reloads were returned for evaluation.Visual inspection and functional testing were conducted on the returned device.According to our analysis process, thirteen samples were taken randomly to be analyzed.Visual analysis of the returned samples revealed that thirteen mic4034 reloads were received with no apparent damage.The packages were opened and the reloads were tested for functionality with a test device for its functionality.Upon functional testing of the clips, the instrument loaded, retained, and deployed clips as intended.The clips were as intended and conform to our manufacturing requirements.As part of quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the clips performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Events reported via: 2210968-2022-02260, 2210968-2022-02261, 2210968-2022-02262, 2210968-2022-02263, 2210968-2022-02259, 2210968-2022-02264, 2210968-2022-02265, 2210968-2022-02266, 2210968-2022-02267, 2210968-2022-02268,2210968-2022-02269, 2210968-2022-02270, 2210968-2022-02272, 2210968-2022-02273.
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