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

Model Number VH-4000

Device Problems Mechanical Problem (1384); Device Remains Activated (1525)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/26/2023

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 would continue to send power to the cutting jaws even though toggle switch was no longer being physically activated.They noticed that they would have to physically push the toggle switch to the inactive position (forward) in order to stop the continuous activation of power to the cutting jaws.This would happen during the case for about "70 percent" of the toggle switch activations.They were able to complete the case with the same harvesting kit.There was no significant delay caused by this complaint.No harm to the patient.

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 Description

N/a.

Manufacturer Narrative

Trackwise# (b)(4).The device was returned to the factory for evaluation on 01/10/2024.An investigation was conducted on 01/11/2024.A visual inspection was conducted.Signs of clinical use and evidence of blood and charred material were observed on the device.The heater wire was observed to be flexed away from the base of the hot jaw and detached from the tip of the jaw.The clear silicone insulation of both the hot and cold jaws was observed to be intact with no visual defects.The c-ring 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; it produced an audible tone from the power supply upon activation and produced visible steam and heat during ten (10) 3-second activations, however it did not always shut off when the toggle was released.During four (4) of the activations, the device remained activated when the toggle was released but the jaws were still closed.A temperature and resistance test was conducted to evaluate the device function per hemopro 2 final test 90523436 rev w.The resistance value was measured at.69 ohms which is within specification.The device passed the temperature measurements test.The displayed temperature increased and turned green within the 2 second specified timeframe.The displayed temperature decreased once the toggle swivel was released.An engineer evaluation was conducted on 01/29/2024 with the following results: "the vh-4000 hemopro2 tool had signs of clinical use on the jaws and handle of the complaint device.The handle was observed to have a significant amount of dried blood on it.The complaint device was connected to the complaint lab¿s hemopro power supply (c-vh-3010), hemopro2 adapter (c-vh-4020), and hemopro2 extension cable (c- vh-4030).The on/off power switch on the hemopro power supply (c-vh-3010) was moved to the on position and the toggle on the handle of the complaint vh-4000 hemopro2 tool was pulled back to the activation (power on) position.The complaint vh-4000 hemopro2 tool heated up normally.When the toggle on the handle was released, it returned to the off position and the heating element in the jaws stopped heating, which is normal.The complaint vh-4000 hemopro2 tool was cycled on and off an additional thirty times.The complaint vh-4000 hemopro2 tool worked normally for all thirty cycles.The handle of the complaint vh-4000 hemopro2 tool was opened to further investigate why the user of the complaint vh-4000 hemopro2 tool had reported that, ¿they would have to physically push the toggle switch to the inactive position (forward) in order to stop the continuous activation of power to the cutting jaws¿.There was dried blood observed on the inside of the handle of the complaint vh-4000 hemopro2 tool.Specifically, there was dried blood seen at the pivot location of the thumb toggle and at the location where the collar actuator slides on the guide in the handle half.Next, the thumb toggle was removed from handle to investigate further.Dried blood was found on the surfaces that the thumb toggle pivots on.There was also dried blood on the surface of the collar actuator that slides on the ribs of the handle.O from the evidence of the dried blood inside the handle of the complaint vh-4000 hemopro2 tool, it is determined that coagulating blood had caused the thumb toggle to not return to the inactive (power off) position which resulted in the heater in the jaws to remain powered on.Based on the returned condition of the device, the investigation results, and the engineer evaluation, the reported failures "device remains activated" and "mechanical problem" as well as the analyzed failure "material twisted/bent wire" were confirmed.The dhr, shop floor paperwork was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.The lot # 3000354208 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.

Manufacturer Narrative

Trackwise#: (b)(4).

Event Description

N/a.

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: 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: 18603365
• MDR Text Key: 334844569
• Report Number: 2242352-2024-00053
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700406
• UDI-Public: 00607567700406
• Combination Product (y/n): N
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VH-4000
• Device Catalogue Number: VH-4000
• Device Lot Number: 3000354208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose