Catalog Number C-VH-4001 |
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 03/20/2018 |
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 quit working.(failed to deliver energy) they tried changing out the cord and then the pigtail but neither fixed the problem.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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Catalog # changed to c-vh-4001.(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 on the tool handle.Traces of blood and charred tissues were observed on the jaws.Microscopic inspection showed the heater wire to be slightly flexed away but remained attached to the jaw.The silicone insulation appeared 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 vh-3010 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.A temperature and resistance evaluation was conducted to evaluate the device function.The resistance value was measured at 0.672 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 evaluation, the reported failure mode "failure to deliver energy" was not confirmed.The analyzed failure mode "bent wire" was confirmed.Specific actions for the analyzed failure mode "bent wire" 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 quit working.(failed to deliver energy) they tried changing out the cord and then the pigtail but neither fixed the problem.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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