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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV VASO VIEW HEMOPRO; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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MAQUET CV VASO VIEW HEMOPRO; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Catalog Number C-VH-3000
Device Problems Device Remains Activated (1525); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/05/2018
Event Type  malfunction  
Manufacturer Narrative
(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.
 
Event Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro remained activated.Device was plugged in and when the trigger was activated prior to using it on the patient the heat was stuck in the on position and there was a continuous audible sound even though the trigger had been released.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Event Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro remained activated.Device was plugged in and when the trigger was activated prior to using it on the patient the heat was stuck in the on position and there was a continuous audible sound even though the trigger had been released.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
Internal complaint number: (b)(4).Autonumber: cs-cpl-2018-01347.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 jaws.Microscopic inspection showed that the heater wire on the hot jaw was slightly flexed but remained attached to the jaw.The silicone insulation boot appeared intact.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 jaws.Microscopic inspection showed that the heater wire on the hot jaw was slightly flexed but remained attached to the jaw.The silicone insulation boot appeared intact.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 activated when the power was turned on.And de-activated when the toggle was released.The blue toggle was pulled all the way and clicked then the device activated.The device de-activated when the toggle was released.The audible tone stopped upon release of the toggle.The tool handle was opened to evaluate the internal components.No visible defects were observed to the toggle.The switch was examined.No residue or contamination was seen on the switch.Based on the returned condition of the device and the evaluation results , the reported failure ¿device remains activated" was not confirmed.The analyzed failure "material twisted/bent" was confirmed.
 
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Brand Name
VASO VIEW HEMOPRO
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
MDR Report Key8207120
MDR Text Key131916755
Report Number2242352-2018-01380
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
PMA/PMN Number
K052274
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/05/2019
Device Catalogue NumberC-VH-3000
Device Lot Number25141264
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2018
Date Manufacturer Received12/21/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Weight74
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