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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO VH-3500; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO VH-3500; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number VASOVIEWHEMPRO VH-3500
Device Problems Particulates (1451); Fitting Problem (2183)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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.
 
Event Description
The hospital reported general feedback that did not pertain to a particular vasoview hemopro vh-3500 unit that was used for endoscopic vein harvesting procedures.They have had a lot of units where the hand cautery is very difficult to advance within the housing channel.Happens multiple times a day to the team.Also they noticed a curl of plastic that comes from somewhere and frequently ends up in the tunnel.
 
Manufacturer Narrative
Trackwise (b)(4).A lot history record review was completed for lots 25154978, 25155039, and 25155215 the last 3 lots shipped to the account prior to the event/aware date.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.
 
Event Description
The hospital reported general feedback that did not pertain to a particular vasoview hemopro vh-3500 unit that was used for endoscopic vein harvesting procedures.They have had a lot of units where the hand cautery is very difficult to advance within the housing channel.Happens multiple times a day to the team.Also they noticed a curl of plastic that comes from somewhere and frequently ends up in the tunnel.
 
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Brand Name
VASOVIEWHEMPRO VH-3500
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ 07470
MDR Report Key11333091
MDR Text Key232151617
Report Number2242352-2021-00138
Device Sequence Number1
Product Code GEI
UDI-Device Identifier00607567701250
UDI-Public00607567701250
Combination Product (y/n)N
PMA/PMN Number
K153194
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVASOVIEWHEMPRO VH-3500
Device Catalogue NumberVH-3500
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received02/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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