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 05/16/2018 |
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 not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 failed to cauterize and was removed.Another hemopro vasoview 2 was attached and the case was completed.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 with evidence of charred tissues were observed on the jaws.On microscopic inspection, the heater wire was observed to be flexed away from the middle part but remained attached at the tip and at the base.The silicone insulation on both cold and hot jaws were intact with no cracks nor peeling.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.During the pre-cautery test, it produced steam and audible beeping sound during five (5) 3-second activations.To evaluate the safety shut down system, a poly-fuse activation test was performed 5 times over 10 minutes.The device shut off after the period of sustained activation and reactivated after a 10-second cooling period with no incident each time.The jaws were cleaned gently with saline and gauze pad as indicated in the instructions for use.An activation and transection capability test were performed over five (5) repetitions using "max life test method" (bacon test).The device activated and transected tissue five (5) times with no cautery failure observed.A temperature and resistance evaluation was conducted to evaluate the device function.The resistance value was measured at 0.686 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 switch was released.Based on the returned condition of the device and the results of the investigation, the reported failure "failure to cut" was not confirmed.The analyzed failure "material twisted/bent" was confirmed.Specific actions for the analyzed failure "material twisted/bent" 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 failed to cauterize and was removed.Another hemopro vasoview 2 was attached and the case was completed.The hospital did not report any patient effects.
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Search Alerts/Recalls
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