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

Model Number VH-4000

Device Problem No Apparent Adverse Event (3189)

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

Event Type  malfunction  

Manufacturer Narrative

Tw id# (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

Related to (b)(4) and (b)(4).The hospital reported insulation tip not on jaws in back to back cases with the same lot number and decided to be proactive and remove the 11 remaining vh-4000 vasoview hemopro 2 units from the shelf.These items have not been used.No patient involvement.

Event Description

N/a.

Manufacturer Narrative

Tw # (b)(4).The devices were returned to the factory for evaluation on 12/15/2023.An investigation was conducted on 01/09/2024.Devices were returned inside their respective product packaging.A visual inspection was conducted.No signs of clinical use was observed.Each product tray was sealed inside each respective pouch.The jaws of the 11 devices were observed to be intact, with no visual defects observed.There was no peeling of the clear silicone insulation on both the hot and cold jaws on any of the devices jaws.Onetrack (b)(4) was returned in an opened state.There were no signs of clinical use and no evidence of blood was observed.There were no visual defects observed on the harvesting device.The heater wire was observed to be intact.There were no visual defects observed on the clear silicone insulation on both the cold and hot jaws.No peeling or delamination was observed.Based on the returned condition of the devices and no specific failure reported, there were no failures observed.The dhr shop floor paperwork was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.The lot # 3000347797 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: 18454871
• MDR Text Key: 332522145
• Report Number: 2242352-2024-00012
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• 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: 3000347797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: N/A.