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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 Structural Problem (2506); Material Protrusion/Extrusion (2979)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/14/2018
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 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 wire within the jaws did not lay flat.While using the device, the wire protruded from the jaw.Device was removed from the patient, and a replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
Internal complaint number: (b)(4).Autonumber : # (b)(4).The hp1 device was returned to the factory for evaluation.Signs of clinical use and evidence of blood were observed.A visual inspection was conducted.Heavy tissue buildup and blood were observed on the jaws.Sign of blood were observed on the harvesting tool handle.The heater wire was observed to be twisted away from the center of the hot jaw.The heater wire remained attached at the base of the hot jaw.No other failures were observed.Based on the results of the evaluation, the reported failure mode ¿material twisted/bent; wire¿ was confirmed.
 
Event Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro wire within the jaws did not lay flat.While using the device, the wire protruded from the jaw.Device was removed from the patient, and 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 Key8143783
MDR Text Key129886955
Report Number2242352-2018-01267
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 12/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/24/2019
Device Catalogue NumberC-VH-3000
Device Lot Number25140541
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2018
Device Age YR
Date Manufacturer Received03/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age75 YR
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