MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HEMOPRO 2 ADAPTOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VH-4020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2025
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 after procedure.Hemopro2 adaptor cord ripped.They went to remove evh hp2 extension cord from the adaptor cord and had some difficulty.When finally got it, the end of the adaptor cord ripped as well.There was no delay.There was no patient harm.
Additional Manufacturer Narrative
(b)(4).Updated sections: b4, g3, g6, h2, h3, h6, h11.The device was returned to the factory for evaluation on 04/17/2025.An investigation was conducted on 04/17/2025.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The adaptor end that connects to the power supply was observed to be intact.The connector end that connects to the harvesting device was observed to be detached from the adaptor, exposing the inner contents of the adaptor.No other visual defects were observed.Based on the returned condition of the device as well as the evaluation results, the reported failure "break" was confirmed.A manufacturing engineering evaluation was conducted.The complaint was confirmed.A visual evaluation was performed on june 30, 2025.During the evaluation it was observed that the tool connector piece had detached from the insulation jacket.After inspection of the adapter cable it was determined that the insulation jacket had been forcibly detached from the tool connector piece.This is supported by objective evidence of the torn wires and the jagged edges on the insulation jacket.Conclusion: the manufacturing engineering evaluation performed on june 30, 2025, determined the probable root cause of the reported failure mode "material integrity problem, break" was determined to be user error.The insulation jacket had been forcibly detached from the tool connector piece.This is supported by the presence of the torn wires and the jagged edges on the insulation jacket, which would take a significant amount of force.Based on the manufacturing engineering evaluation, the reported failure "break" was 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: HEMOPRO 2 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: 21961739
• Report Number: 2242352-2025-0000518
• Device Sequence Number: 21131568
• Product Code: GEI
• UDI-Device Identifier: 00607567700918
• UDI-Public: (01)00607567700918
• 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): 07/03/2025

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
• Date Returned to Manufacturer: 04/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown