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

Model Number	C-VH-4020
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tw id# (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.The lot number has not been provided despite multiple attempts to obtain the information.Therefore, the production identifier fields are not available.
Event or Problem Description
The hospital reported issue with hemopro2 adaptor.
Additional Manufacturer Narrative
Trackwise#: (b)(4).The device was returned to the factory for evaluation on 12/02/2024.An investigation was conducted on 12/16/2024.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 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.An activation and transection capability test was performed over four (04) repetitions using "max life test method stm2048073 rev aa.The device successfully transected tissue four (04) times.Based upon the received condition of the device, it is not possible to confirm the reported complaint as there was no device malfunction.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.

• 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: 20568164
• Report Number: 2242352-2024-0001190
• Device Sequence Number: 12610411
• Product Code: GEI
• UDI-Device Identifier: 00607567700918
• UDI-Public: (01)00607567700918
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 02/14/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown