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	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Updated sections: b4, d9, g3, g6, h2, h6, h11.Corrected section: d10, h3-device returned, h6-codes 4115 & 3221 removed.The device was returned to the factory for evaluation on 12/04/2025.An investigation was conducted on 12/04/2025.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.Both connector ends were observed to be intact.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 did emit an audible beeping sound and the evh reference tool did produce steam or heat.An activation and transection capability test was performed over four (4) repetitions using "max life test method.The device successfully transected tissue four (4) times.Based on the returned condition of the device as well as the evaluation results , the reported failure "failure to deliver energy" was not confirmed.The reported device is an oem device; therefore, a lot/serial 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.
Additional Manufacturer Narrative
(b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, hemopro2 extension cable did not work.No power/energy.Unknown how old the extension cable was or how many sterilizations.No issues with power supply reported.Power setting unknown.Audible beep and lights on unknown.Power supply wasn't the issue reported and was working.The surgeon opened up a new vh-4030 to complete the case.Patient was in the room.No patient effects or delays were reported.

• 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: 23664030
• Report Number: 2242352-2025-0001232
• Device Sequence Number: 21058191
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 01/02/2026
• 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: NO.
• Patient Sex: Unknown