MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HEMOPRO II ADAPTOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VH-4020
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during a standard endoscopic saphenous vein harvesting procedure, they encountered a problem with the hemopro ii adaptor.They used the same device to complete the procedure.There was a delay in the procedure since they did not have a second device.They were forced to perform a surgical conversion of the vein graft harvest.This led to a surgical conversion, thus a prolonged harvest time and a considerably larger surgical incision.
Additional Manufacturer Narrative
Tw (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
Additional Manufacturer Narrative
Tw # (b)(4).Updated sections: b4,d9,g3,g6,h2,h3,h6,h11.The device was returned to the factory for evaluation on 10/20/2025.An investigation was conducted on 10/21/2025.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There were no visual defects observed on the inttact adaptor.An electrical evaluation was conducted.The adapter was connected to a reference power supply vh-3010 and reference extension cable with no visual or physical difficulties.A pre-cautery test was performed per the instruction for use with a reference hemopro 2 and reference power supply vh-3010 at level 3.0.The device failed the pre-cautery test; it did not produce steam or heat during 5-second activations and shut off when the toggle was released.No additonal testing was conducted due to the harvesting device not powering on.Based upon the received condition of the device, as well as the evaluation results and the evaluation results, while there was no failure mode reported, the analyzed failure "failure to deliver energy" was observed.The reported device is an oem device, therefore, a lot history review was not applicable.A lot/serial number was not provided and the specific product lot/serial number cannot be identified from a ship history, therefore it is impossible to obtain a certificate of conformance.
Event or Problem Description
N/a.

• Brand Name: HEMOPRO II ADAPTOR
• 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: 22644495
• Report Number: 2242352-2025-0000887
• Device Sequence Number: 8718731
• Product Code: GEI
• UDI-Device Identifier: 00607567700918
• UDI-Public: (01)00607567700918
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2025

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-4020
• Device Catalogue Number: VH-4020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 83 KG