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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC VASOVIEW HEMOPRO 2
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MAQUET CARDIOVASCULAR, LLC VASOVIEW HEMOPRO 2 Back to Search Results
Model Number C-VH-4000
Device Problem Image Resolution Poor (1306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/06/2015
Event Type  malfunction  
Event Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 jaw became very loose and the dr was afraid it would rip the side branches.Also the dissection tunnel was not transparent but looked like scratches that seriously hampered visibility.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.(b)(4).
 
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Brand Name
VASOVIEW HEMOPRO 2
Manufacturer (Section D)
MAQUET CARDIOVASCULAR, LLC
wayne NJ
Manufacturer Contact
tina evancho
45 barbour pond drive
wayne, NJ 07470
9737097265
MDR Report Key4898304
MDR Text Key6072531
Report Number2242352-2015-00550
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K101274
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/01/2016
Device Model NumberC-VH-4000
Device Lot Number25109979
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/10/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/10/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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