(b)(4) date sent: 11/30/2023 d4: batch # a9cj27 additional information was requested and the following was obtained: ¿as far as i am aware device did not feed clips¿ "no adverse consequences or delayed surgery time reported in this complaint." investigation summary the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the msm20 device was received with no damage to the external components.Upon cycling, the instrument was noted to be empty and locked out.The instrument is designed to lockout after all the clips have been fired; therefore a potential cause for the customer reported experience is the firing of all of the clips, as a result, the instrument could no longer be fire due to the activation of the lockout mechanism.As the device was returned empty for evaluation we are unable to investigate further the issue of ¿would not feed" and ¿would not hold" and ¿malformed clips" and ¿clip cutting".The device was disassembled to verify the condition of the internal components and no anomalies were noted.The event described could not be confirmed as the device was returned empty.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.
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