(b)(4).Date sent: 4/23/2024 d4: batch # a9eg7x 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 el5ml device was received with no damage to the external components.Upon cycling, the instrument was noted to be empty and locked out.In addition, one(1) malformed clip and three(3) conforming clips, and four(4) unformed clips were returned inside a plastic bag.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.In order to evaluate the condition of the internal components of the device, it was disassembled.Upon disassembling, no anomalies were found.The instrument has an orange indicator that appears on the top of the handle as a reference for the user as to the number of clips remaining.The event described could not be confirmed as the device was returned empty.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: when the 13th clip is fired, an orange bar will begin to appear in the indicator window on top of the device handle.The orange bar fills the indicator window when the final clip is fired.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.
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