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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); Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/31/2018
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, vasoview hemopro 2 after completing the dissection, the device was inserted to start cauterizing branches.However, after doing a short fasciotomy the harvester noticed that the tips of the bisector were bent.Due to this defect, the device could not be used to complete the harvesting process.The defective device was removed from the surgical field and a new hemopro 2 device was opened.The case was finished without any further complications.There were no adverse outcomes due to this defect.
 
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 tissue were observed on the jaws.A microscopic inspection was conducted.The heater wire was observed to be slightly flexed away from the hot jaw, but remained attached at the base and tip of the hot jaw.It was also observed that the tool shaft at the pivot pin was bent.The shrink tube was observed to be peeled at certain spots, exposing the metal portion of the shaft.Based upon the evaluation results, the reported failure "bent wire" was confirmed, as well as confirmed for the analyzed failures "bent shaft", "peeled shrink tube¿.Specific actions for the reported confirmed failure mode are being maintained and documented under maquet¿s failure investigation report (fir) system.
 
Event Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 after completing the dissection, the device was inserted to start cauterizing branches.However, after doing a short fasciotomy the harvester noticed that the tips of the bisector were bent.Due to this defect, the device could not be used to complete the harvesting process.The defective device was removed from the surgical field and a new hemopro 2 device was opened.The case was finished without any further complications.There were no adverse outcomes due to this defect.
 
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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
Manufacturer (Section G)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
Manufacturer Contact
45 barbour pond drive
wayne, NJ 07470
MDR Report Key7630454
MDR Text Key112294403
Report Number2242352-2018-00585
Device Sequence Number1
Product Code GEI
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 Nurse
Type of Report Initial,Followup
Report Date 06/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2019
Device Catalogue NumberC-VH-4000
Device Lot Number25135783
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/01/2018
Initial Date FDA Received06/22/2018
Supplement Dates Manufacturer Received08/13/2018
Supplement Dates FDA Received08/17/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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