MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2 (W/VASOSHIELD); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VH-4001
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Tw (b)(4).Event site name exceeded character limitations: (b)(6).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 that the harvester was 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 using the vasoview hemopro 2 (w/vasoshield).After cutting almost all of the branches, the harvester attempted to cut a larger branch before getting ready to remove the vein from the leg.After using techniques to seal the larger branch, the harvester made several attempts to cut the branch.However, after several attempts, the device would not cut through the branch even though the device would activate and seemed like energy was being applied to the branch.Therefore, the harvester made a small incision over the branch, placed surgical clips, and cut the larger branch with a scissors.No injury occurred due to the defect.The only surgical delay was the time needed to cut the branch which was about 3 minutes.The defective device was saved so it could be returned for evaluation and the appropriate getinge representative was notified about the complaint.The harvester was able to finish the case without opening up a second kit.
Additional Manufacturer Narrative
Tw (b)(4).Updated sections: b4, b5, g3, g6, h2, h3, h6, h11.The device was returned to the factory on (b)(6) 2025.An evaluation was performed on the same day.Visual inspection showed signs of clinical use and evidence of blood.Charred dried tissue was observed on the tool jaws.There were no visual defects observed on the intact heater wire or the intact clear silicone insulation on both the cold and hot jaws.The tool shaft which should be normally straight was observed to be bent at the middle part.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.Despite the bent shaft, the toggle switch can still be manipulated.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 three (3) repetitions using "max life test method.The device successfully transected tissue(bacon) three (3) times.The jaws were gently cleaned of debris and char with a saline and gauze pad as indicated in the direction for use (b)(4).A temperature and resistance test was not conducted due to the bent shaft.Based on the returned condition of the device as well as the evaluation results, the reported failure to cut was not confirmed.However, the analyzed failure material twisted/bent shaft was observed.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device serial/lot conforms to all applicable product specifications.The lot # 3000499906 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 or the analyzed failure.
Event or Problem Description
The hospital reported that the harvester was 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 using the vasoview hemopro 2 (w/vasoshield).After cutting almost all of the branches, the harvester attempted to cut a larger branch before getting ready to remove the vein from the leg.After using techniques to seal the larger branch, the harvester made several attempts to cut the branch.However, after several attempts, the device would not cut through the branch even though the device would activate and seemed like energy was being applied to the branch.Therefore, the harvester made a small incision over the branch, placed surgical clips, and cut the larger branch with a scissors.No injury occurred due to the defect.There was only a very small amount of bleeding due to this (less than 5 to 10 ml).No transfusion was needed.The only surgical delay was the time needed to cut the branch which was about 3 minutes.The defective device was saved so it could be returned for evaluation and the appropriate getinge representative was notified about the complaint.The harvester was able to finish the case without opening up a second kit.

• Brand Name: VASOVIEW HEMOPRO 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: 23908429
• Report Number: 2242352-2025-0001328
• Device Sequence Number: 15751746
• Product Code: GEI
• UDI-Device Identifier: 00607567700451
• UDI-Public: (01)00607567700451(10)3000499906(17)270828
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 3000499906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2025
• 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.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown