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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV VASOVIEW HEMOPRO 2; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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MAQUET CV VASOVIEW HEMOPRO 2; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Catalog Number C-VH-4000
Device Problems Bent (1059); Break (1069); Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/30/2018
Event Type  malfunction  
Manufacturer Narrative
(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 not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
 
Event Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 tool broke above the jaws.Hospital did not need to retrieve anything from the patient's leg, it stayed intact however was bent and unusable.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 tool broke above the jaws.Hospital did not need to retrieve anything from the patient's leg, it stayed intact however was bent and unusable.There were no consequences or impact to the patient.
 
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Brand Name
VASOVIEW HEMOPRO 2
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
MDR Report Key7627602
MDR Text Key112291262
Report Number2242352-2018-00575
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
PMA/PMN Number
K101274
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/12/2020
Device Catalogue NumberC-VH-4000
Device Lot Number25137155
Was Device Available for Evaluation? No
Date Manufacturer Received08/28/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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