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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV VASO VIEW HEMOPRO; CLAMP, VASCULAR
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MAQUET CV VASO VIEW HEMOPRO; CLAMP, VASCULAR Back to Search Results
Catalog Number C-VH-3000
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 01/24/2017
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 cautery in the evh set malfunctioned.The metal part raised the bottom ledge and did not work anymore.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
(b)(6).(b)(4).The device was returned to the factory for evaluation.Signs of blood and clinical use were observed.The heater wire was flexed away from the hot jaw but remained attached at the base and the tip of the jaw.Slight amount of charred tissue was observed on the hot jaw.No other visual defects were observed.The device was evaluated for electrical/cautery function.A pre-cautery test was performed per the instruction for use (ifu) 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 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 while the cable connections were manipulated with no observed failure.An activation and transection capability test was performed over ten (10) repetitions using max life test method.The device activated and transected tissue ten (ten) times with no cautery failure observed.The handle was opened to evaluate the internal components.No visible defects were observed to the toggle.The switch was examined under microscopy.No residue or contamination was seen on the switch.We were unable to observe any electrical issues or failure to energize for the complaint unit during our testing.Based on the return condition of the device and the evaluation results, the reported complaint is not confirmed for "failure to cut" but is confirmed for the failure mode "bent wire".
 
Event Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro cautery in the evh set malfunctioned.The metal part raised the bottom ledge and did not work anymore.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
CLAMP, VASCULAR
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 Key6347844
MDR Text Key68228854
Report Number2242352-2017-00172
Device Sequence Number1
Product Code DXC
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/21/2017
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 Date11/09/2017
Device Catalogue NumberC-VH-3000
Device Lot Number25129386
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/20/2017
Is the Reporter a Health Professional? Yes
Device AgeYR
Initial Date Manufacturer Received 01/24/2017
Initial Date FDA Received02/21/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/07/2016
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 Age69 YR
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