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

Model Number	VH-3000-W
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
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 during an endoscopic vessel harvesting procedure, vasoviewhempro (ous) vh-3000 jaw did not deactivate after the toggle was released.The power was set to 3.Problem was solved after changing to another device.There was no procedural delay.There was no patient harm.
Additional Manufacturer Narrative
Trackwise#: (b)(4).The device was returned to the factory for evaluation on 05/14/2024.An investigation was conducted on 05/21/2024.A visual inspection was conducted.Signs of clinical use and evidence of blood and charred material were observed.The heater wire and gray silicone insulation of both the hot and cold jaws was observed to be intact with no visual defects.An electrical evaluation was conducted.A pre-cautery test was performed per the instruction for use (ifu) with a reference cable, adapter, and reference power supply vh-3010 at level 3.0.The device failed the pre-cautery test.When the power supply was turned on, the device activated immediately with the jaws glowing orange and producing heat in the open position.No excessive smoke was observed.Movement of the toggle switch opened and closed the jaws, however it had no effect on the activation of the device.A tone was audible from the power supply during activation.An engineer evaluation was conducted on 06/10/2024 with the following results: the complaint device was connected to the complaint lab¿s hemopro power supply (c-vh-3010) and hemopro extension cable (c-vh-3030).The on/off power switch on the hemopro power supply was toggled to the on position and the toggle on the handle of the complaint vh-3000-w hemopro tool was pulled back to the activation (power on) position.It was observed that heating element on the jaws of the complaint vh-3000-w hemopro tool heated up, which is normal.When the thumb toggle on the handle was released, it returned to the off position and the heating element in the jaws stopped heating.This is normal.Next, the handle of the complaint vh-3000-w hemopro tool was opened to further evaluate the complaint device.After opening the hemopro tool handle and removing the thumb toggle, it was observed that there was solder flux on the outside of the switch.The solder flux was specifically found to be on the switch actuator plunger and lever arm pivot point.Solder flux in either of these locations can cause the switch to get stuck in the activated ¿on¿ position.Based on the returned condition of the device, investigation results, and engineer evaluation, the reported failure "device remains activated" was confirmed.Specific actions for the reported failure mode are being maintained and documented under maquet's corrective and preventive action (capa) system.The lot # 3000365379 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.
Event or Problem Description
N/a.

• Brand Name: VASOVIEW HEMOPRO, OUS
• 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
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 19311390
• Report Number: 2242352-2024-00519
• Device Sequence Number: 3063318
• Product Code: GEI
• UDI-Device Identifier: 00607567700413
• UDI-Public: 00607567700413
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K052274
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2024

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 Expiration Date: 01/11/2025
• Device Model Number: VH-3000-W
• Device Catalogue Number: VH-3000-W
• Device Lot Number: 3000365379
• 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: 04/24/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown