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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC VASOVIEW 7 XB; ENDOSCOPIC VESSEL HARVESTING
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MAQUET CARDIOVASCULAR, LLC VASOVIEW 7 XB; ENDOSCOPIC VESSEL HARVESTING Back to Search Results
Model Number VH-3200
Device Problem Image Resolution Poor (1306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
The hospital reported that there were a few incidents of the purple dissection tip on the vasoview 7 xb being blurry.The hospital did not report any patient effects.
 
Manufacturer Narrative
Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.(b)(4).
 
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Brand Name
VASOVIEW 7 XB
Type of Device
ENDOSCOPIC VESSEL HARVESTING
Manufacturer (Section D)
MAQUET CARDIOVASCULAR, LLC
wayne NJ
Manufacturer (Section G)
MAQUET CARDIOVASCULAR, LLC
45 barbour pond drive
wayne NJ 07470
Manufacturer Contact
tina evancho
45 barbour pond drive
wayne, NJ 07470
9737097265
MDR Report Key4535850
MDR Text Key5511304
Report Number2242352-2015-00057
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041981
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 01/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVH-3200
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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