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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 Problems Sticking (1597); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/10/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.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, physician assistant was using the vasoview hemopro device to seal and cut branches but found that it kept getting stuck on the c-ring.Upon closer inspection, she observed that the jaw had thinned out and wasn¿t performing as expected.Hospital was asked if the device was inserted before inserting the scope and she let me know that she had been inserting the scope first every time.She also told me that she did not see any aberrant pieces in the tunnel.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
(b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed.Blood and charred tissue were observed on the heater wire.The silicon insulation was observed to be peeled away from the cold jaw at the tip, leaving the part of the metal cold jaw exposed.The peeled silicon was not returned for evaluation.A microscopic inspection was conducted.The heater wire was observed to be slightly flexed at the center of the hot jaw, but remained attached at both the tip and base of the hot jaw.Based on the return condition of the device, the reported failure "peeled jaw" was confirmed as well as the analyzed failure mode "bent wire" was confirmed.
 
Event Description
The hospital reported that during an endoscopic vein harvesting procedure, physician assistant was using the vasoview hemopro device to seal and cut branches but found that it kept getting stuck on the c-ring.Upon closer inspection, she observed that the jaw had thinned out and wasn¿t performing as expected.Hospital was asked if the device was inserted before inserting the scope and she let me know that she had been inserting the scope first every time.She also told me that she did not see any aberrant pieces in the tunnel.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
Manufacturer (Section G)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
Manufacturer Contact
45 barbour pond drive
wayne, NJ 07470
MDR Report Key7496280
MDR Text Key107823581
Report Number2242352-2018-00437
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052274
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 05/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/19/2019
Device Catalogue NumberC-VH-3000
Device Lot Number25137838
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2018
Is the Reporter a Health Professional? Yes
Device Age YR
Date Manufacturer Received06/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/19/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age77 YR
Patient Weight106
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