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

Model Number	VH-4020
Medical Device Problem Codes	Intermittent Continuity (1121); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id# (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 while harvesting radial artery, the hemopro2 adaptor (vh-4020) only worked intermittently, and the extension cable was switched out.This did not change the situation and the team realized that it was the adapter.When the extension cable and the adapter were held together, it would work, and so the case was completed with the circulator holding the two together until the case was complete.No pt injury.
Additional Manufacturer Narrative
(b)(4).Updated section: b4, g3, g6, h2, h6, h11.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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Tw#(b)(4).The device was returned to the factory for evaluation on (b)(6) 2024.An investigation was conducted on (b)(6) 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 returned 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 passed the pre-cautery test; it did produce steam and heat during 5-second activations and shut off when the toggle was released.A polyfuse electrical test was performed with the same reference power supply, extension cable, hemopro 2 and returned adapter cable; the reference device shut off after the period of sustained activation and reactivated after 10-second cooling period with no incident each time, however it only passed when the adaptor was bent while attached to the cable.After unbending the adaptor at the base of the reference harvesting device, the device would turn off.No further testing was conducted due to the intermittent power caused by the connection problem that was observed.An engineer evaluation was requested.The following is manufacturing engineering's evaluation of the vh-4020 hemopro 2 adapter, complaint onetrack #1193351, which was returned for the reported failure of "intermittent continuity.The complaint was confirmed.0 a reference hemopro 2 device was connected to the complaint lab's hemopro power supply (c-vh-3010), hemopro2 adapter (c-vh-4020), and hemopro2 extension cable (c-vh-4030).The on/off power switch on the hemopro power supply (c-vh- 3010) was moved to the on position and the toggle on the handle of the vh-4000 hemopro2 tool was pulled back to the activation (power on) position.The hemopro power supply immediately started making an audible beeping sound that indicated electrical energy was being delivered to the reference hemopro 2 device.Wet gauze was placed between the jaws and there was visible steam.The reference hemopro 2 device was then connected to the same hemopro power supply (c-vh-3010), the complaint hemopro 2 adapter (onetrack 1193351), and the same hemopro2 extension cable.The on/off power switch on the hemopro power supply (c-vh-3010) was moved to the on position and the toggle on the handle vh- 4000 hemopro2 tool was pulled back to the activation (power on) position.The hemopro power supply immediately started making an audible beeping sound that indicated electrical energy was being delivered to the reference hemopro 2 device.However, when the toggle was released and then pulled back again there was no audible beeping sound.The complaint hemopro 2 adapter worked intermittently, confirming that the adapter cable was not performing as intended and was not able to deliver energy consistently.Based on the returned condition of the device as well as the evaluation results and the engineer evaluation, the reported failures "intermittent continuity" and "connection issue" was confirmed.

• Brand Name: HEMOPRO2 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: 21138159
• Report Number: 2242352-2025-0000046
• Device Sequence Number: 6825415
• Product Code: GEI
• UDI-Device Identifier: 00607567700918
• UDI-Public: (01)00607567700918
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 05/08/2025

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-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: 12/19/2024
• Supplement Date Received by Manufacturer: 02/14/2025; 05/08/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 02/18/2025; 05/09/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EXT CORD.
• Patient Sex: Unknown