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	Insufficient Information (4580)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during evh procedure, none of the hemopro2 extension cables available were working with vh-4000 or vh-3010 except one.The customer stated that all ¿old¿ cords needed to be replaced with the new cords that were compatible with the new vh-3010.A site visit was conducted during procedure.During inspection, the acct mgr observed that the single cord reported as functional was not a getinge manufactured (non-oem) cord and he had never seen such cord.This was communicated with both circulating nurse and harvester.Functional testing was performed on the non-oem cord and confirmed it operates with the vh-3010 and the harvesting tool of the vh-4000 by both visual steaming of the harvesting tool jaw and audible beeping of the vh-3010.Subsequent testing of all the getinge oem cords that were reported as not working demonstrated normal function.All oem cords were verified as fully operational and that was communicated to customer.The customer is requesting replacement of all cords that they reported as nonfunctional as well as ordering information of the non-oem cord.The acct mgr told the customer that he had no information on the non-oem cord.Case was completed with non-oem cord.
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, d9, g3, g6, h2, h3, h6, h11.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.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.The certificate of conformance was reviewed for the serial # (b)(6).The vendor certifies that this device lot conforms to all applicable product specifications and there were no non-conformances identified for the manufacturing batch.

• 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: 23645772
• Report Number: 2242352-2025-0001228
• Device Sequence Number: 10122804
• Product Code: GEI
• UDI-Device Identifier: 00607567700925
• UDI-Public: (01)00607567700925(11)230331
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 12/16/2025

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
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown