MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HEMOPRO2 EXTENSION CABLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VH-4030
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 hemopro2 extension cable was not working.It was replaced with another device to complete the case.No patient impact or delays were reported.
Additional Manufacturer Narrative
Tw # (b)(4).Updated sections: b4,d4-udi#,g3,g6,h2,h3,h6,h11.The device was returned to the factory for evaluation on 02/02/2026.An investigation was conducted on 02/03/2026.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There were no visual defects observed on the intact cable.One connector end was observed to be intact.The other connector end was observed to be missing a fin on the side of the collar.An electrical evaluation was conducted.A mechanical evaluation was conducted using a reference adaptor, power supply and hemopro 2 device.The cable was able to be connected to the adaptor with no physical or visual difficulties.The reference harvesting device was attached to the cable, however it wasn't able to be snapped into place due to the missing fin.An electrical evaluation was conducted.A pre-cautery test was performed per the instruction for use (ifu) with a reference hemopro 2 evh tool, reference adapter and reference power supply set at level 3.0.The device failed the pre-cautery test.There was no power to the harvesting device.Based on the return condition of the device as well as the evaluation results, the reported failure "failure to deliver energy" was confirmed as well as the analyzed failures "break-collar" and "connection problem" were observed.The reported device is an oem device, therefore, a lot history review was not applicable.A lot number was not provided and the specific product lot 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: HEMOPRO2 EXTENSION CABLE
• 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: 24257058
• Report Number: 2242352-2026-0000048
• Device Sequence Number: 8309779
• Product Code: GEI
• UDI-Device Identifier: 00607567700925
• UDI-Public: (01)00607567700925
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 02/04/2026

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-4030
• Device Catalogue Number: VH-4030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown