(b)(4).Date sent: 11/9/2023.D4: batch # x95d7m.Additional information was requested and the following was obtained: "harmonic device touched the clip, and the clip broke into half.The other half was found on the tissue which was taken out from the patient." "the broken clip was found inside the patient.There was no change (e.G.Additional porthole) when retrieving the clip." 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.In addition, the tyvek was returned along with the instrument.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.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.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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