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

Model Number	VH-4001
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise # (b)(4).Updated section: b4, g3, g6, h2, h3, h6, h11.The device was returned to the factory for evaluation on 01/28/2025.A photograph was provided by the account.A photographic evaluation 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.The heater wire was observed to be flexed and twisted away from the hot jaw from the base of the hot jaw with detachment at the tip of the hot jaw.No other visual defects were observed.An investigation was conducted on 03/10/2025.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.The heater wire was observed to be flexed and twisted away from the hot jaw from the base of the hot jaw with detachment at the tip of the hot jaw.No additional testing was conducted due to the condition of the heater wire.Based on the returned condition of the device as well as the photographic evaluation, the reported failure "material twisted/ bent wire" was confirmed.The lot # 3000440982 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.Specific actions for the reported failure mode are being maintained and documented under maquet's corrective and preventive action (capa) system.
Additional Manufacturer Narrative
Tw (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 that during a saphenous endoscopic vessel harvesting procedure using vasoview hemopro 2 (w/vasoshield) (vh 4001), after completing the dissection process, the harvester started to use the hemopro 2 device to perform branch ligation.However, after ligating several branches the harvester noticed that the metal in the jaws of the harvesting tool had pulled away from the outer coating of the jaws.This created a "fork-like" appearance.Due to this defect, the device was deemed unsafe for use and was immediately removed from the surgical field.A new hemopro 2 kit was opened up and the remainder of the case was finished with no other complications.The only procedural delay was the time needed to open a new hemopro 2 kit which was about 3 to 5 minutes.No injuries occurred due to the defect and the generator was correctly set at a setting of 3.Per the photo, it shows that the metal in the jaws of the device had pulled away from the outer coating of the jaws.

• 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: 21378919
• Report Number: 2242352-2025-0000160
• Device Sequence Number: 19795709
• Product Code: GEI
• UDI-Device Identifier: 00607567700451
• UDI-Public: (01)00607567700451(10)3000440982(17)261207
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

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: 3000440982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2024
• 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.
• Patient Sex: Unknown