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

Model Number VH-4000

Device Problems Electrical /Electronic Property Problem (1198); Device Remains Activated (1525); Material Twisted/Bent (2981)

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

Event Date 01/18/2024

Event Type  malfunction  

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

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 device stayed engaged (cutting and cauterizing) when the toggle was brought to the neutral position (as evidence by the beeping on the generator and smoke coming from the jaws when in the neutral position).The jaws had to be opened for it to stop burning.Using the same device, the auto shut off engaged and the device stopped working in the middle of ligating a branch.The customer stopped burning for a minute or two.Then when they reattempted burning, the device shut off after a few seconds of being activated.The power was set to 3.With the same device, the wire came apart from the jaws.The jaws were not open (even slightly) when inserted into the cannula with no resistance noted.At that point the device was then removed and a new device was used and worked without issue.There was no procedural delay.No injury to patient.

Manufacturer Narrative

Trackwise#: (b)(4).The device was returned to the factory for evaluation on 01/30/2024.An investigation was conducted on 01/31/2024.A visual inspection was conducted.Signs of clinical use and evidence of blood and charred material were observed.A microscopic inspection was conducted.The heater wire was observed to be flexed away from the tip 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.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 passed the pre-cautery test.It produced visible steam and heat during ten (10) 3-second activations and shut off when the toggle was released with no excessive smoke observed.The device did not remain activated when the toggle was in the neutral position, which is normal.A tone was audible from the power supply upon activation.To evaluate the safety shut down system, a polyfuse activation test was performed 5 times over 10 minutes.The device shut off after the period of sustained activation and reactivated after the 10-second cooling period with no incident each time.The jaws were gently cleaned of debris and char with a saline and gauze pad as indicated in the direction for use (cv000008979).No final testing or activation and transection capability test was performed due to the damaged state of the heater wire.Based on the returned condition of the device and investigation results, the reported failures "electrical/electronic property problem" and "device remains activated" were not confirmed, however the reported failure "material twisted/bent; wire" was confirmed.The lot # 3000357805 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: 18677930
• MDR Text Key: 335089898
• Report Number: 2242352-2024-00099
• Device Sequence Number: 1
• Product Code: GEI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• 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: 3000357805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: VH-3010 HEMOPRO POWER SUPPLY
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 112 KG