Trackwise#: (b)(4).The device was returned to the factory for evaluation on 12/07/2022.An investigation was conducted on 07/24/2023.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.Charred material was observed on the intact heater wire.There were no visual defects observed on the intact gray silicone insulation on both the cold and hot jaws.An electrical evaluation was conducted.A pre-cautery test was performed per the instruction for use (ifu) with a reference adapter, reference cable, and reference power supply vh-3010 at level 2.5.The device failed the pre-cautery test; it did not produce visible steam and heat during ten (10) 3-second activations and shut off when the toggle was released.To evaluate the safety shut down system, a polyfuse activation test was performed 5 times over 10 minutes.The device did not power on.An engineer evaluation was conducted.The complaint device was connected to the complaint lab¿s hemopro power supply (c-vh-3010) and hemopro extension cable (c-vh-3030).The on/off power switch on the hemopro power supply (c-vh-3010) was toggled to the on position.Next, the toggle on the handle of the complaint vh-3500 hemopro tool was pulled back to the activation (power on) position, it was observed that the heating element on the jaws of the complaint vh-3500 hemopro tool did not heat up which is not normal.Additionally, it was observed while the toggle on the handle was pulled back to the activation (power on) position, that the hemopro power supply (c-vh-3010) did not beep.This indicates that power was not being delivered to the complaint vh-3500 hemopro tool.This is also not normal and indicates a break in the electrical circuit in the complaint device.Next, the complaint vh-3500 hemopro tool handle was opened to determine the location and cause of the break in the device¿s electrical circuit.After opening the handle, the toggle was removed from the handle to expose the switch inside the handle.The wire from the pigtail connector, which is normally soldered to the normally open (n.O.) switch terminal, was found to be detached from the n.O.Switch terminal.Examination of the normally open (n.O.) switch terminal showed an impression in the solder located near the edge of the switch terminal.The impression in the solder is the location where the pigtail connector wire had been placed on the n.O.Switch terminal during soldering.Examination of the pigtail connector wire showed that wire breakage was not the cause of the wire detachment.Additionally, there were no visible signs of solder on the exposed metal portion of the wire.Based on the visual evidence, the pigtail connector wire had become disconnected from the normally open (n.O.) switch terminal due to the incorrect positioning of the exposed metal portion of the wire onto the n.O.Switch terminal during soldering.Based on the tqc point in the hemopro soldering station work instructions mcv00034815, this solder joint would not be acceptable and should have been rejected.Based on the results of the evaluation, the reported failure "failure to deliver energy" was confirmed.The lot#: 3000271901 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.
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