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

Model Number VASOVIEW HEMOPRO 2

Device Problem Device Remains Activated (1525)

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

Event Date 10/04/2022

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure the vasoview hemopro 2 jaws of the harvesting tool didn't shut off.They stated that failure happened towards the end of harvest and the jaws remained active with visible arcs of energy coming from the jaws of the device.The jaws remained active for approximately one minute and when they couldn't get it to shut off, they unplugged it.They had another device brought in to complete the harvest.No patient harm was reported.

Manufacturer Narrative

Trackwise id(b)(6).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 10/10/2022.An investigation was conducted on 10/17/2022.Signs of clinical use and evidence of blood were observed on the harvesting device handle and jaws.Evidence of charred material was also observed between the jaws.The heater wire was observed to be flexed away from the hot jaw and was detached from the tip of the jaw.No defects on the clear silicone insulation were observed on the hot or cold jaws.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 visible steam and heat during ten (10) 3-second activations with no excessive smoke observed, but did not shut off each time the toggle was released.A tone was audible from the power supply upon activation.The toggle switch was observed to "stick", causing the device to remain activated.Greater than normal physical force had to be used to slide the toggle switch forward, open the jaws, and stop activation.To evaluate the safety shut down system, a polyfuse activation test was performed 5 times over 10 minutes.The device would intermittently remain activated after releasing the toggle back to the off position.An engineer evaluation was conducted on 11/02/2022 with the following results (see attached email): the complaint device was connected to the complaint lab hemopro power supply (c-vh-3010), hemopro2 adapter (c-vh-4020), and hemopro2 extension cable (cvh-4030).The on/off power switch on the hemopro power supply (c-vh-3010) was toggled to the on position.The complaint vh-4000 hemopro2 tool self-activate which is not normal.Next, the vh-4000 hemopro2 tool complaint device was cycled on and off ten (10) times.The result was that the complaint device would intermittently remain activated after the handle toggle was moved to the off position.Additionally, when the toggle on the handle was pulled back to activated position, it was observed that the jaws did not fully close which is also not normal.Next, the complaint vh-4000 hemopro2 tool handle was opened to determine the cause of the heating element on the primary jaw remaining activated.After opening the handle, it was observed that the collar on the yoke rod had shifted in the proximal direction from its normal location on the yoke rod.Next, the flex shaft that includes the yoke rod and collar was removed from the handle assembly of the vh-4000 hemopro2 tool.Without the use of tools, the collar was pulled off the yoke rod with minimal resistance, which is not normal.As per work instruction 90523415 rev h, a torque of 3.65 lbf-in is applied to the collar set screw to secure the collar in place.Based on the returned condition of the device, the investigation results, and the engineer evaluation, the reported failure "device remains activated", as well as the analyzed failures "material twisted/bent wire" and "mechanical issue", was confirmed.Specific actions for the failure modes are being maintained and documented under maquet's corrective and preventive action (capa) system.The lot # 3000262456 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.

• 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: 15686300
• MDR Text Key: 305605268
• Report Number: 2242352-2022-00881
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VASOVIEW HEMOPRO 2
• Device Catalogue Number: C-VH-4000
• Device Lot Number: 3000262456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STRYKER ENDOSCOPY TOWER
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 116 KG