MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC EVHHEMOPRO 2 W/VASOSHIELD; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VH-4001
Medical Device Problem Code	Intermittent Continuity (1121)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise# (b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
Event or Problem Description
The hospital reported they were using the vasoview hemopro 2 (w/vasoshield) to harvest the saphenous vein.After the dissection process was completed, the harvester started to perform branch ligation.After cutting several branches, the device stopped working.Even thought the device was not used long and was not activated for an extended period, the harvester assumed that the device had overheated.Therefore, the harvester waited at least 45 seconds before using the device again.However, from this time on the device would intermittently work with no obvious reason for the device failing to activate.In other words, the device would not always activate when the toggle was pulled.The case was finished using the same device with no adverse outcomes to the patient.Due to the intermittent activation, there was a slight surgical delay of about 3 to 5 minutes to complete the harvest.
Additional Manufacturer Narrative
Trackwise - (b)(4).Updated field: b1, b4, g3, g6, h2, h3, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h11.The device was returned to the factory for evaluation on 06/12/2025.An investigation was conducted on 6/1/29025.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.There were no visual defects observed on the clear intact silicone insulation on both the cold and hot jaws or the intact heater wire.An electrical evaluation was conducted.A pre-cautery test was performed per the instruction for use (ifu) with a reference cable, adapter and reference power supply at level 3.0.The device turned on and an audible sound was heard when activating the toggle.The device passed the pre-cautery test.It produced visible steam and heat during ten (10) 3-second activations.The device was tested for the safety shut down system as the device would turn on, and produced visible steam.An activation and transection capability test was performed over four (04) repetitions using "max life test method stm2048073.The device successfully transected tissue five (5) times.The jaws were gently cleaned of debris and char with a saline and gauze pad as indicated in the direction for use (cv000008979).A temperature and resistance test was conducted to evaluate the device function per hemopro 2 final test 90523436.The resistance value was measured at.68 ohms which is within specification.The device passed the temperature measurements test.The displayed temperature increased and turned green within the 2 second specified timeframe.Based on the returned condition of the device as well as the evaluation results, the reported failure ""intermittent continuity" was not confirmed.The lot # 3000463127 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.
Event or Problem Description
N/a.

• Brand Name: EVHHEMOPRO 2 W/VASOSHIELD
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 22359153
• Report Number: 2242352-2025-0000757
• Device Sequence Number: 18142063
• Product Code: GEI
• UDI-Device Identifier: 00607567700451
• UDI-Public: (01)00607567700451(10)3000463127(17)270314
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K101274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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
• Operator of Device: Health Professional
• Device Model Number: VH-4001
• Device Catalogue Number: VH-4001
• Device Lot Number: 3000463127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO CONCOMITANT MEDICAL PRODUCTS WERE USED.
• Patient Sex: Unknown