Catalog Number C-VH-3000 |
Device Problems
Failure to Deliver Energy (1211); Sticking (1597); Failure to Shut Off (2939)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/23/2018 |
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 were no ncmr¿s for the reported lot number.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 toggle switch was not able to be deactivated so energy was being generated and not able to turn off.It was as if the toggle switch was stuck in the on position.Customer was able to disconnect power from the device.The customer opened another device and completed 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.Signs of clinical usage and no evidence of blood were observed.Microscopic inspection was conducted.The heater wire on the hot jaw was slightly flexed at the center of the hot jaws.The heater wire remained attached at the tip and base of the hot jaw.The silicone insulation was observed to be intact with no defects.An electrical evaluation was conducted.A pre-cautery test was performed per the instruction for use with a reference cable and reference power supply vh-3010 at level 2.5.The device passed the pre-cautery test; it produced visible steam and audible sound during several activations over a period of 10 minutes and shut off when the toggle was released.The pre-cautery test was repeated 10 times with no observed failure.The tool handle was opened to evaluate the internal components.No visible defects were observed to the toggle.Microscopic inspection showed no residue or contamination on the inner switch mechanism.Based on the returned condition of the device and the results of the evaluation, the reported failure mode "device remains activated" was not confirmed, but was confirmed for the analyzed failure mode "material twisted bent; wire".
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro toggle switch was not able to be deactivated so energy was being generated and not able to turn off.It was as if the toggle switch was stuck in the on position.Customer was able to disconnect power from the device.The customer opened another device and completed the procedure.The hospital did not report any patient effects.
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Search Alerts/Recalls
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