Catalog Number C-VH-4000 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/13/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.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 polyfuse engaged causing the device to not activate.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Manufacturer Narrative
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(b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed.Blood was observed near the base of the jaws.A microscopic inspection was conducted.The heater wire was slightly flexed at the center of the jaw towards the tip of the hot jaw, but remained attached at the base and tip of the hot jaw.No other visual defects were observed.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 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.The jaws were cleaned of debris and char gently with saline and gauze pad as indicated in the instructions for use.A temperature and resistance evaluation was conducted to evaluate the device function.The resistance value was measured at 0.67 ohms which is within hemopro 2 final test specification.The device passed the temperature measurement 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 unable to be confirmed but analyzed failure "bent wire" was confirmed.Specific actions for the analyzed failure mode are being maintained and documented under maquet¿s failure investigation report (fir) system.
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 polyfuse engaged causing the device to not activate.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Search Alerts/Recalls
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