MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO VH-3500; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VASOVIEWHEMPRO VH-3500

Device Problem Failure to Deliver Energy (1211)

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

Event Date 10/28/2022

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure that the vasoview hemopro vh-3500 jaw was not activating/failed to deliver energy.The power setting was set to 2.5.A new device was opened to complete the case.No procedural delay.No injury to the patient.

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.

Manufacturer Narrative

Trackwise # (b)(4).The device was returned to the factory for evaluation on 12/07/2022.An investigation was conducted on 12/14/2022.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The heater wire was observed to be intact, with no visual defects observed.The gray 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 adapter, reference cable, and reference power supply vh-3010 at level 2.5.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.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 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 (cv000006999).An activation and transection capability test was performed over four (4) repetitions using "max life test method stm2048073 rev aa.The device successfully transected tissue four (4) times.Based on the results of the evaluation, the reported failures "failure to deliver energy¿ was not confirmed.The lot # 3000269857 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: VASOVIEWHEMPRO VH-3500
• 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: 16015987
• MDR Text Key: 308446441
• Report Number: 2242352-2022-01021
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K153194
• 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: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2023
• Device Model Number: VASOVIEWHEMPRO VH-3500
• Device Catalogue Number: C-VH-3500
• Device Lot Number: 3000269857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 83 KG