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

Model Number	VH-4030
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that cautery functionality was compromised and was restored once the defective hemopro2 extension cable was swapped out for a new one.
Additional Manufacturer Narrative
(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
(b)(4).Updated sections: b4,b5,d4 lot#, exp date, udi#,d9,g3,g6,h2,h3,h6,h11.The device was returned to the factory for evaluation on 12/18/2025.An investigation was conducted on 12/22/2025.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There were no visual defects observed on the intact cable.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 with no physical or visual difficulties observed.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 passed the pre-cautery test.The power supply emitted an audible beeping sound and the evh reference tool produced steam and heat.An activation and transection capability test was performed over four (4) repetitions using "max life test method.The reference device successfully transected tissue four (4) times.Based on the returned condition of the device and the results of the evaluation, the reported failure "electrical /electronic property problem" was not confirmed.The reported device is an oem device.The certificate of conformance was reviewed for the lot #12411138.The vendor certifies that this device lot # conforms to all applicable product specifications and there were no non-conformances identified for the manufacturing batch.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, the defective hemopro2 extension cable was swapped out for a new one as the cautery functionality was compromised, it was restored once the defective cable was swapped.There was no delay.There was no patient harm.

• 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: 23618616
• Report Number: 2242352-2025-0001217
• Device Sequence Number: 15943166
• Product Code: GEI
• UDI-Device Identifier: 00607567700925
• UDI-Public: (01)00607567700925
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 12/22/2025

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-4030
• Device Catalogue Number: VH-4030
• Device Lot Number: 12411138
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/22/2025
• 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
• Patient Sex: Unknown