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

Model Number VH-3500

Device Problem Failure to Deliver Energy (1211)

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

Event Date 03/07/2024

Event Type  malfunction  

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.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro vh-3500 did not energize.They had a slight delay while they switched the cable and it still didn't work.A new kit was opened and that one was ok to finish the case with.No patient harm was reported.

Manufacturer Narrative

Trackwise#: (b)(4).The device was returned to the factory for evaluation on 03/19/2024.An investigation was conducted on 03/26/2024.A visual inspection was conducted.Signs of clinical use and evidence of blood and charred material were observed on the device.The cannula, c-ring, heater wire, and gray silicone insulation of the jaws were observed to be intact with no visual defects.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 failed the pre-cautery test.The device did not activate or produce visible steam or heat during f ten (10) 3-second activations.No tone was audible from the power supply upon activation.An engineer evaluation was conducted on 4/15/2024 with the following results: the complaint device was connected to the complaint lab¿s hemopro power supply (c-vh-3010) and hemopro extension cable (c-vh-3030).When the on/off power switch on the hemopro power supply (c-vh-3010) was toggled to the on position and the toggle on the handle of the complaint vh-3500 hemopro tool was pulled back to the activation (power on) position, it was observed that heating element on the jaws of the complaint vh-3500 hemopro tool did not heat up which is not normal.The electrical continuity of the complaint vh-3500 hemopro tool was tested using the complaint lab¿s multimeter (calibration id# 14054, exp.04/30/2024).The electrical continuity of the complaint vh-3500 hemopro tool was tested with the toggle on the handle of the complaint device pulled back to the activation (power on) position.The result was no electrical continuity through the complaint device which is not normal and indicates a break in the electrical circuit in the complaint device.Next, the complaint vh-3500 hemopro tool was inspected externally and then the handle was opened to determine the cause of the break in the device¿s electrical circuit.There was evidence of clinical usage observed on the heating elements of the jaws.After opening the handle and removing the thumb toggle it was observed that the wire normally solder to the common (c) terminal was broken and no longer connected to the common terminal.The wire broke at the location on the wire where the wire insulation ends, and the stripped portion of the wire begins.The stripped portion of the wire was observed to be still soldered to the common terminal.Based on the returned condition of the device, investigation results, and engineering evaluation, the reported failure "failure to deliver energy" was confirmed.Specific actions for the reported failure mode are being maintained and documented under maquet's corrective and preventive action (capa) system.The lot # 3000368165 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
• 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: 18992374
• MDR Text Key: 339002554
• Report Number: 2242352-2024-00301
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 3000343264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 05/24/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CABLE
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 125 KG