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

Model Number VH-4000

Device Problems Intermittent Continuity (1121); Electrical /Electronic Property Problem (1198); Peeled/Delaminated (1454)

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

Event Date 12/18/2023

Event Type  malfunction  

Manufacturer Narrative

Tw (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

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 not long after they started using the cutting tool, maybe 4 or 5 cuts, it immediately started shutting down whereby the feedback mechanism of the power supply prevented energy from being delivered to the cutting tool.They waited approximately 60 seconds to allow the feedback mechanism to reset so that they could proceed with the procedure but the feedback mechanism would immediately kick in and constantly prevent the power supply from delivering energy to the cutting tool after only a few short cuts with the cutting tool.The constant interruption from the feedback mechanism prevented the cutting tool from cutting branches properly during the radial artery harvest.They also noticed the black insulation behind the jaws starting lift up.Therefore, the decision was made to stop using the hemopro2 kit and replace it.The replacement worked fine without any feedback mechanism interruptions and the case was completed without further delay.Very minor delay.No harm.

Event Description

N/a.

Manufacturer Narrative

Trackwise#: (b)(4).Corrected sections: h6: medical device ¿ problem code corrected from "1121" to "1198." the device was returned to the factory for evaluation on 01/15/2024.An investigation was conducted on 01/17/2024.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed.Evidence of charred material was also observed between the heater wire and on the jaws.A microscopic inspection was conducted.The heater wire and clear silicone insulation of the jaws were observed to be intact.The black shaft was observed to be peeled and bent at the tip above the jaws.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 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 with no excessive smoke observed.A tone was audible from the power supply upon activation.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 the 10-second cooling period with no incident each time.An activation and transection capability test was performed over (04) repetitions using "max life test method stm2048073.The device activated and transected tissue (04) times with no cautery failure observed and with no excessive smoke observed.A temperature and resistance test was conducted to evaluate the device function per hemopro 2 final test 90523436 rev w.The resistance value was measured at.698 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.Based on the returned condition of the device and the investigation results, the reported failure "electrical problem" was not confirmed, however the reported failure "peeled; shaft " and the analyzed failure "material twisted/bent; shaft" were confirmed.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device serial/lot conforms to all applicable product specifications.The lot#: 3000345735 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: 18476629
• MDR Text Key: 332897101
• Report Number: 2242352-2024-00018
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• 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: 3000345735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.