The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 cautery would not activate.Device appeared intact with no imperfections or defects noted.Customer states all connections were checked, and all other equipment was functioning in the operating room.Power cord was intact, but was swapped out in order to troubleshoot.Device continued to fail to cauterize.There were no parts missing, or broken on the device.No parts fell into or onto the patient.There was no patient harm.The case went on without event.
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Trackwise#: (b)(4).Corrected sections: h6--medical device ¿ problem code corrected from "1198" to "1211".The device was returned to the factory for evaluation on 12/29/2022.An investigation was conducted on 01/10/2023.A visual inspection was conducted.Signs of clinical use and no evidence of blood were observed on the device.The heater wire and clear silicone insulation of the jaws were observed to be intact with no visual defects.An electrical evaluation was conducted.A pre-cautery test was performed per the direction for use (dfu) with a reference cable, adapter, and reference power supply vh-3010 at level 3.0.The device passed the pre-cautery test; it produced 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 shut off after the period of sustained activation and reactivated after 10-second cooling period with no incident each time.An activation and transection capability test was performed over four (4) repetitions using "max life test method stm2048073 rev aa.The device successfully transected tissue four (4) times.The jaws were gently cleaned of debris and char with a saline and gauze pad as indicated in the direction for use (cv000008979).A temperature and resistance test was conducted to evaluate the device function per hemopro 2 final test 90523436 rev w.The resistance value was measured at.67 ohms which is within specification.The device passed the temperature measurements test.The displayed temperature increased and turned green within the 2 second specified timeframe.The displayed temperature decreased once the toggle swivel was released.Based on the results of the evaluation, the reported failure "failure to deliver energy¿ was not confirmed.The lot # 3000262459 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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