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

Model Number	VH-4030
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 during the setup of the case, the new hemopro2 extension cable was cracked at the connection.This was discovered when the tray was opened.A new cord was used to complete the procedure.There was no delay.There was no patient harm.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
(b)(4).Updated fields: b4, g3, g6, h2, h3, h6, h11.The device was returned to the factory for evaluatiion on 12/08/2025.A visual inspection was conducted on 12/08/2025.Signs of clinical use and no evidence of blood was observed.The cable was observed to be intact with no visual defects noted.Both connectors were observed to be intact with no visual defects observed.An electrical evaluaion was conducted.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 stm2048073.The device successfully transected tissue four (4) times.Based on the returned condition of the device as well the evaluation results, the reported failure "crack" was not confirmed.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.

• 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: 23815115
• Report Number: 2242352-2025-0001301
• Device Sequence Number: 15975598
• Product Code: GEI
• UDI-Device Identifier: 00607567700925
• UDI-Public: (01)00607567700925
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Date Returned to Manufacturer: 12/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/16/2026
• 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
• Patient Sex: Unknown