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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2 CLAMP, VASCULAR

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MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2 CLAMP, VASCULAR Back to Search Results
Model Number VASOVIEW HEMOPRO 2
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/25/2019
Event Type  malfunction  
Manufacturer Narrative
Trackwise id #(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 2 jaws were not opening and closing properly and that the toggle switch on the handle was getting stuck. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
 
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Brand NameVASOVIEW HEMOPRO 2
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ 07470
Manufacturer (Section G)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ 07470
Manufacturer Contact
45 barbour pond drive
wayne, NJ 07470
MDR Report Key9509841
MDR Text Key187055180
Report Number2242352-2019-01410
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101274
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/08/2021
Device Model NumberVASOVIEW HEMOPRO 2
Device Catalogue NumberVH-4000
Device Lot Number25147896
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received01/29/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/09/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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