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

Model Number	C-VH-4020
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during an endoscopic vessel harvesting procedure, hemopro2 adaptor seemed to not transmit energy to the jaws when attempting to seal first branch.Although the power supply was plugged in and the power indicator light was glowing, there was no beeping and no indication of burning/sealing by the jaws.The extension cable was plugged into both the adaptor and the hpii technology.The power supply was turned off and on, and the cables detached and re-attached with no change.Right before the power supply and adaptor were to be changed out, the device suddenly started working.After a few burns, it did not work again.The adaptor and power supply were changed out at that point.After the procedure, harvesters attempted to recreate the problem to isolate the issue, but the device worked continuously with the original power supply and adaptor combination.Harvester suspects the adaptor was to blame.There was no patient injury.
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.
Additional Manufacturer Narrative
Trackwise#: (b)(4).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.

• 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: 19995891
• Report Number: 2242352-2024-00933
• Device Sequence Number: 20929414
• Product Code: GEI
• UDI-Device Identifier: 00607567700918
• UDI-Public: 00607567700918
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Number of Events Summarized: 1
• Summary Report (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): 09/24/2024

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: 07/29/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 09/25/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EXTENSION CABLE, POWER SUPPLY
• Patient Sex: Unknown