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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 Thermal Decomposition of Device (1071); Flare or Flash (2942); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/12/2018
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 got stuck in the on position.They quickly removed the device from the patient.Upon removal, the tip flared and burned, then it was unplugged and removed from the surgical field.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 on the tool jaws.Charred tissue was evident on the jaws.It was observed that a portion of the silicone insulation on the hot jaw was peeled and detached at the distal end, which left the metal part exposed.The detached portion of the insulation was not returned to the factory.The insulation that remained attached to the hot jaw looked cracked and charred due to its ash like appearance.The heater wire on the hot jaw was flexed but remained attached to the jaw.The insulation on the cold jaw appeared intact.An electrical evaluation was conducted.A pre-cautery test was performed per the instruction for use with a reference cable and reference power supply vh-3010 at level 2.5.The device passed the pre-cautery test; it produced visible steam and audible sound during several activations over a period of 10 minutes and shut off when the toggle was released.The pre-cautery test was repeated 10 times with no observed failure.The tool handle was opened to evaluate the internal components.No visible defects were observed to the toggle.Microscopic inspection showed no residue or contamination on the inner switch mechanism.Based on the returned condition of the device and the evaluation results, the reported failure "device remains activated" was not confirmed.The analyzed failures "thermal decomposition of device," "material twisted/bent" and "peeled" were all confirmed.
 
Event Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro got stuck in the on position.They quickly removed the device from the patient.Upon removal, the tip flared and burned, then it was unplugged and removed from the surgical field.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 Key8218863
MDR Text Key132230520
Report Number2242352-2019-00017
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 01/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/12/2019
Device Catalogue NumberC-VH-3000
Device Lot Number25142727
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2018
Is the Reporter a Health Professional? Yes
Device Age YR
Date Manufacturer Received02/08/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/10/2018
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 Age65 YR
Patient Weight73
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