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

Model Number VH-3500

Device Problem Failure to Cut (2587)

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

Event Date 03/05/2024

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro vh-3500 burning function would not burn nearly as fast as usual.The hemopro power cord, power supply, and eventually a new bisector were all switched out without change in cauterization.The power output on the power supply was increased to at least 5 without change as well.New device and new power source were tried and the case was completed in a much slower fashion due to the issues.There was never harm to the patient, but it did significantly increase the harvesting time as they were forced to wait at least 3x as long for the bisector to cauterized the branches of the greater saphenous vein.

Manufacturer Narrative

Tw 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

N/a.

Manufacturer Narrative

Trackwise#: (b)(4).Updated sections: b4, d4, d9, g3, g6, h2, h3, h4, h6, h10.

Manufacturer Narrative

Trackwise (b)(4) the device was returned to the factory for evaluation on 03/19/2024.An investigation was conducted on 03/28/2024.A visual inspection was conducted.The harvesting device was returned inside the cannula.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 base of the intact jaws.There were no visual defects observed on the intact cannula or intact c-ring.There were no visual defects observed on the intact gray silicone insulation on both the cold and hot jaws.There were no visual defects observed on the intact heater wire.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.No excessive smoking was observed during testing.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 did successfully transect tissue four (4) times.No excessive smoking was observed during testing.Based on the returned condition of the device, the investigation results, the reported failure, "failure to cut¿ was not confirmed.The lot # 3000362064 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.

Event Description

N/a.

• Brand Name: VASOVIEW HEMOPRO
• 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: 18981688
• MDR Text Key: 338633650
• Report Number: 2242352-2024-00294
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567701250
• UDI-Public: 00607567701250
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 3000362064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/16/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CORDS, HP POWER SUPPLY.
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 97 KG