(b)(4).Other- device evaluated by authorized third part technician.The device history record (dhr) for intellicart system serial number (b)(4) was reviewed noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.On (b)(6) 2019, it was reported from (b)(6) medical center that the unit began to smoke and there was an electrical fire.On (b)(6) 2019, a zimmer biomet authorized repair technician was contacted about the cart and dispatched to be at the site.The technician arrived at the site and upon inspection of the unit found that there was no fire, or evidence that the unit had caused the smoke.The technician, and biomed at the site inspected the unit and found that both cylinders had been full of fluid when the surgeon was cauterizing during a case.The smoke from the process was being pulled into the cylinder, which had limited air space due to the amount of fluid.The limited space in the cylinder cause the smoke to leave the cart where possible, and appeared as an electrical issue to the account.Additionally, while inspecting the device the technician found that the ge filter was failing and replaced it with a buffalo filter (part #30041) and then verified that the unit was functioning as intended.The technician then returned the unit to service without further incident.The device was tested, inspected, and repaired.This complaint cannot be confirmed, as a technician was unable to duplicate or find evidence of the reported event upon inspection of the device.Additionally, for this reason a root cause cannot be selected for the reported event.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.
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