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

Model Number VH-4000

Device Problem Intermittent Continuity (1121)

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

Event Date 01/25/2023

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 cautery was cutting out intermittently.The cautery seemed to be cutting out after 5-6 seconds of use and then would reactivate and work for another 5-6 seconds before cutting out again.Changes in power cable and generator did not solve the issue.A second kit was opened and the procedure was completed without further incident.There was no harm to the patient and only minimal time disruption to the case.

Manufacturer Narrative

Trackwise 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

N/a.

Manufacturer Narrative

Trackwise#: (b)(4).The device was returned to the factory for evaluation on 01/31/2023.An investigation was conducted on 02/09/2023.A visual inspection was conducted.The harvesting device was returned inside the cannula.There were no visual defects observed on the cannula or the intact c-ring.A mechanical evaluation was conducted.The harvesting device was removed from the cannula with no physical or visual difficulties observed.Signs of clinical use and evidence of charred material was observed on the heater wire.The heater wire was observed to be intact with no visual defects observed.The clear silicone insulation on both the cold and hot jaws was observed to be intact with no visual defects observed.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 at level 3.0.The device did turn on and an audible sound was heard when activating the toggle.The device passed the pre-cautery test.It produced visible steam and heat during ten (10) 3-second activations.The device was tested for the safety shut down system as the device would turn on, and produced visible steam.A temperature and resistance test was conducted to evaluate the device function.The resistance value was measured at.67 ohms which is within specification.The device passed the temperature measurements test.The displayed temperature increased and turned green within the 2 second specified timeframe.The displayed temperature decreased once the toggle swivel was released (complaint lab hemopro 2 test station bmram 14290, due 03/31/2023).Based on the returned condition of the device and the results of the evaluation, the reported failure "intermittent continuity" was not confirmed.The lot # 3000278333 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: 16417102
• MDR Text Key: 310180797
• Report Number: 2242352-2023-00138
• 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
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• 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: 3000278333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2023
• Date Manufacturer Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male