It was reported that a 66-year-old female patient underwent a laparoscopic paraesophageal hernia repair with harmonic scalpels/shears and the white pad tip of the harmonic scalpel hand piece started to melt and slide off.The device was returned on june 4, 2019 in a plastic bag with the distal tip wrapped with tissue.None of the original packaging was returned.It was also observed that the tissue pad was partially melted.Per the failure mode and effects analysis (fmea) of the device, this is likely due to "activation of device without tissue between the blade and the pad." the presence of melting on the pad, as well as observed eschar on parts of the jaw, is indicative that the device was still actuated within the operative field after sealing had been completed.Being able to actuate and operate the device in this manner, could affect the functionality of the device and prevent it from operating going forward.The device was attached to the gen11 generator.The device was identified, and the system display showed that it was ready for device usage.The reported issue was confirmed.However, as device was used during the procedure, no conclusion as to the root cause for the reported issue was determined, though the fmea lists user error - activation of device without tissue between the blade and the pad as the cause of this hazard.An manufacturing record evaluation was performed for the finished device lot# 1966979, and no non-conformances were identified.Manufacturer's ref.No: (b)(4).
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