MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Model Number VH-4000 |
Device Problem
Intermittent Continuity (1121)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/24/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 cautery cutout intermittently.Stopped cutting, heating, beeping, everything.Cautery worked well until later in the procedure when it stated to cutout intermittently.Opened new kit to finish case.No added incisions or time.No patient harm done.
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Manufacturer Narrative
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Trackwise#: (b)(4).The device was returned to the factory for evaluation on 02/20/2024.An investigation was conducted on 02/20/2024.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.There were no visual defects observed on the returned cannula.There were no visual defects observed on the heater wire or clear intact silicone insulation on both the cold and hot jaws.An electrical evaluation was conducted.An electrical evaluation was conducted.A pre-cautery test was performed per the instruction for use (ifu) with a reference cable, adapter and reference power supply at level 3.0.The device did turn on and an audible sound was heard when activating the toggle.The device passed the pre-cautery test.It produced visible steam and heat during ten (10) 3-second activations.The device was tested for the safety shut down system as the device would turn on, and produced visible steam.An activation and transection capability test was performed over four (04) repetitions using "max life test method (b)(4) 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 (b)(4) rev w.The resistance value was measured at.68 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 returned condition of the device as well as the evaluation results, the reported failure "intermittent continuity" was not confirmed.The lot # 3000359277 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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