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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEWHEMOPRO; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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MAQUET CARDIOVASCULAR LLC VASOVIEWHEMOPRO; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number VASOVIEWHEMPRO (US) VH-3000
Device Problem No Flow (2991)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/01/2020
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 using vasoview hemopro, lack of co2 insufflation in the tunnel when the co2 tube was connected.Co2 settings were 3l/min and 10mmhg.Tubing was changed and the insufflator was changed without success of solving the issue at hand.A second vh-3000 with the same lot# was then opened but the problem persisted.Case was completed without ever being able to resolve the problem with lack of co2.No harm to the patient.
 
Manufacturer Narrative
(b)(4).The device was returned to the factory on (b)(6) 2020.An investigation was conducted on (b)(6) 2020.A visual inspection was conducted.Signs of clinical use and heavy amounts of blood was observed on the cannula.The device was evaluated for the presence or absence of air flow through the distal insufflation tube using a cannula with the help of calibrated uson.A reference endoscope was inserted into a reference vv7 cannula and an air supply was connected to the distal insufflation tubing luer fitting.Air was passed through the insufflation port and was observed to flow freely through the distal port.To verify this, a pouch was sealed over the distal tip of the cannula.Air was passed through the cannula and the pouch was inflated.The air supply was stopped and the pouch stayed inflated.When gentle pressure was applied to the inflated pouch, the pouch deflated slightly, the air was turned back on and the pouch re-inflated.The test was then repeated for the reported cannula.The reference endoscope was inserted into the complaint device and evaluated for air flow.The device passed the air flow test, the co2 insufflation path on the complaint unit was open and unobstructed.The values displayed were within specified acceptable range which is 2196 sccm.Based upon the returned condition of the device and the results of the investigation, the reported failure" no flow" was not confirmed.
 
Event Description
The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro, lack of co2 insufflation in the tunnel when the co2 tube was connected.Co2 settings were 3l/min and 10mmhg.Tubing was changed and the insufflator was changed without success of solving the issue at hand.A second vh-3000 with the same lot# was then opened but the problem persisted.Case was completed without ever being able to resolve the problem with lack of co2.No harm to the patient.
 
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Brand Name
VASOVIEWHEMOPRO
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ 07470
MDR Report Key9993435
MDR Text Key190830389
Report Number2242352-2020-00388
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 04/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/16/2021
Device Model NumberVASOVIEWHEMPRO (US) VH-3000
Device Catalogue NumberVH-3000
Device Lot Number25150292
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/14/2020
Was the Report Sent to FDA? Yes
Date Manufacturer Received04/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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