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

Model Number	C-VH-4020
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The hospital reported that hemopro2 adaptor was not working.After discussions with the customer, it was agreed the issue was caused by user error.There was no patient harm.
Additional Manufacturer Narrative
Trackwise id#: (b)(4).Updated sections: b-4,b-5,d-9,g-3, g-6, h-2, h-3,h-6, h-11.Corrected section b-3 date of event from '7/25/2024" to "7/1/2024".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 a lot/serial number cannot be identified from a ship history, therefore it is impossible to obtain a certificate of conformance.
Event or Problem Description
The hospital reported during an endoscopic vein harvesting procedure, that hemopro2 adaptor was not working.After discussions with the customer, it was agreed the issue was caused by user error.The procedure was completed using the same device.There was procedural delay.There was no patient harm.
Event or Problem Description
The hospital reported during an endoscopic vein harvesting procedure, that hemopro2 adaptor was not working.The procedure was completed using the same device.There was procedural delay.There was no patient harm.
Additional Manufacturer Narrative
Tw # (b)(4).Updated sections: b4,g3,g6,h2,h11.Corrected section: b5.

• Brand Name: HEMOPRO 2 ADAPTOR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• 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: 19982766
• Report Number: 2242352-2024-00923
• Device Sequence Number: 2781640
• Product Code: GEI
• UDI-Device Identifier: 00607567700918
• UDI-Public: 00607567700918
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2025

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: C-VH-4020
• Device Catalogue Number: C-VH-4020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 09/20/2024; 05/20/2025
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/20/2024; 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown