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

Model Number VH-4000

Device Problem Failure to Cut (2587)

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

Event Date 06/24/2023

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure the vasoview hemopro 2 cautery wasn't working properly.The power was on, the heating was slow, but worked.No resistance was noted.They did not try to replace generator or adaptor or cord.They had to open another kit.5 minute delay.No harm to the patient.

Manufacturer Narrative

Trackwise id #(b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.

Manufacturer Narrative

Trackwise#: (b)(4).Updated sections: b4, b5, g4, g7, h2, h6, h10.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure the vasoview hemopro 2 cautery wasn't working properly.The power was on, the heating was slow, but worked.The tool would activate but would take longer to weld/burn through the tissue.2.5 power setting, no resistance was noted.They did not try to replace generator or adaptor or cord.They had to open another kit.5 minute delay.No harm to the patient.

Manufacturer Narrative

Trackwise#: (b)(4).The lot # 3000316988 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: 17329833
• MDR Text Key: 319385122
• Report Number: 2242352-2023-00598
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 08/14/2023

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: VH-4000
• Device Catalogue Number: VH-4000
• Device Lot Number: 3000316988
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/14/2023
• Supplement Dates Manufacturer Received: 07/19/2023; 08/14/2023
• Supplement Dates FDA Received: 08/08/2023; 08/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/17/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1