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

Model Number VASOVIEW HEMOPRO 2

Device Problems Electrical /Electronic Property Problem (1198); Failure to Deliver Energy (1211)

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

Event Date 12/01/2022

Event Type  malfunction  

Manufacturer Narrative

Trackwise id: (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 Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 cautery would not activate.Device appeared intact with no imperfections or defects noted.Customer states all connections were checked, and all other equipment was functioning in the operating room.Power cord was intact, but was swapped out in order to troubleshoot.Device continued to fail to cauterize.There were no parts missing, or broken on the device.No parts fell into or onto the patient.There was no patient harm.The case went on without event.

Manufacturer Narrative

Tw# (b)(4).Corrected section- h6- device code changed to 1211.H3 other text : device discarded.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 cautery would not activate.Device appeared intact with no imperfections or defects noted.Customer states all connections were checked, and all other equipment was functioning in the operating room.Power cord was intact, but was swapped out in order to troubleshoot.Device continued to fail to cauterize.There were no parts missing, or broken on the device.No parts fell into or onto the patient.A new device was used to complete the procedure.There was no patient harm.The case went on without event.

Event Description

N/a.

Manufacturer Narrative

Trackwise # (b)(4).Updated section: b4, g4, g7, h2, h6, h10.The lot # 3000276112 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.Specific actions for the failure mode is being maintained and documented under maquet's corrective and preventive action (capa) system.

• 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: 16025655
• MDR Text Key: 308390827
• Report Number: 2242352-2022-01032
• 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,Followup
• Report Date: 01/20/2023

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
• Device Operator: Health Professional
• Device Model Number: VASOVIEW HEMOPRO 2
• Device Catalogue Number: C-VH-4000
• Device Lot Number: 3000276112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 12/22/2022; 01/20/2023
• Supplement Dates FDA Received: 01/11/2023; 01/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1