Catalog Number C-VH-4000 |
Device Problems
Intermittent Continuity (1121); Intermittent Loss of Power (4016)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 02/09/2019 |
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 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 using vasoview hemopro 2.They experienced intermittent power failures burning branches.Changed the vh-4020 cable and the vh-4030 cable and still had problems.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro 2.They experienced intermittent power failures burning branches.Changed the vh-4020 cable and the vh-4030 cable and still had problems.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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Internal complaint number: (b)(4).Autonumber : # (b)(4).The hp2 device was returned to the factory for evaluation.Signs of clinical use were and evidence of blood were observed.A visual inspection was conducted.Small amounts of tissue and charred blood were observed on the heating element.The heater wire was observed to be flexed away at the center of the hot jaw.The wire remained in place at the base and tip of the jaws.No other failures were observed.The device was evaluated for electrical function.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.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.Based on the results of the evaluation, the reported failure mode ¿intermittent continuity¿ was not confirmed but confirmed for analyzed failure mode ¿material twisted/bent; wire¿.Specific actions for the analyzed failure "material twisted/bent; wire" are being maintained and documented under maquet's failure investigation report (fir) system.
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Search Alerts/Recalls
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