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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 Problem Failure to Deliver Energy (1211)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 that during preparation for an endoscopic vein harvesting procedure, vasoview hemopro cautery would not work.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
Internal complaint - trackwise #:(b)(4).Autonumber # (b)(4).A lot history record review was completed for lots 25142529, 25142873 and 25142746; the last 3 lots shipped to the account prior to the event date.There were no ncmr¿s for the reported lot number.
 
Event Description
The hospital reported that during preparation for an endoscopic vein harvesting procedure, vasoview hemopro cautery would not work.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
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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 Key8207062
MDR Text Key131911467
Report Number2242352-2018-01376
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 Catalogue NumberC-VH-3000
Was Device Available for Evaluation? No
Date Manufacturer Received01/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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