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 Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2023

Event Type  Injury  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 wouldn¿t cauterize the tissue.From the beginning of the case the device was very weak in it's ability to cauterize.They checked all connections and restarted the system with no improvement.They made sure the jaws were clean and the settings appropriate, no improvement.The procedure was completed, but we had to open and use a new kit, new device.The procedure of taking the vein took longer, so that delayed the case.The harvest took marginally longer, maybe 5-10 minutes.There wasn't harm, but the patient probably bled more than if the first device would have worked properly.

Manufacturer Narrative

Tw 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).Corrected section: h6- health effect ¿ impact codes- code "4641" removed, h6- health effect ¿ clinical code-corrected from 4582 changed to 1888.The device was returned to the factory for evaluation on 11/15/2023.An investigation was conducted on 11/20/2023.A visual inspection was conducted.Signs of clinical use and evidence of charred material was observed on the intact heater wire.There were no visual defects observed on the intact heater wire or the intact clear silicone insulation on both the cold and hot jaws.An electrical evaluation was conducted.A pre-cautery test was performed per the direction for use (dfu) with a reference cable, adapter, and reference power supply vh-3010 at level 3.0.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.No excessive smoke and/or steam were observed during the testing.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.An activation and transection capability test was performed over four (4) repetitions using "max life test method (b)(4) rev aa.The device successfully transected tissue four (4) times.Due to the detached state of the heater wire, no final testing could be performed.Based on the results of the evaluation, the reported failure "failure to cut" was not confirmed.The lot # 3000336372 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 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: 18187097
• MDR Text Key: 328737197
• Report Number: 2242352-2023-00988
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VH-4000
• Device Catalogue Number: VH-4000
• Device Lot Number: 3000336372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention