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

Model Number VASOVIEWHEMPRO VH-3500

Device Problem Failure to Cut (2587)

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

Event Date 11/01/2022

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure the vasoview hemopro vh-3500 cautery would not work midway through the case.New cord was used and connections double checked but it still didn't work.A new device was opened to finish the case.The hospital reported no injury to the patient.

Manufacturer Narrative

Trackwise id (b)(6).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.

Manufacturer Narrative

Trackwise#: (b)(4).The device was returned to the factory for evaluation on 12/01/2022.An investigation was conducted on 12/13/2022.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed on the jaws of the harvesting device.The gray silicone insulation of the jaws was observed to be intact with no visual defects.The heater wire was observed to be slightly bent as a result of normal clinical use.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 tiime.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 not successfully transect tissue four (4) times.An engineer evaluation was conducted on 12/21/2022 with the following results (see attached email): the complaint device was connected to the complaint lab hemopro power supply (c-vh-3010) and hemopro extension cable (c-vh-3030).Next, the on/off power switch on the hemopro power supply (c-vh-3010) was switched 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.The hemopro power supply immediately started making an audible beeping sound that indicates electrical energy is being delivered to the complaint vh-3500 hemopro tool but the heating element on the jaws of the complaint vh-3500 hemopro tool did not heat up as expected.Additionally, it was observed that while electrical energy was being delivered to the complaint vh-3500 hemopro tool, the jaws pivot point location on the shaft tip became hot to the touch.This indicated that there was an electrical short near this section of the shaft tip.Next, to evaluate why the shaft tip was getting hot at the jaws pivot point location, the pivot and drive rivets were removed from the shaft tip.This allowed the removal of the jaws and attached wires from the shaft tip.Upon examination of the heating elements in the hot jaw, it was observed that there was physical damage to the proximal end of the heating element.The physical damage resulted in the proximal end of the integrated welder to contact the center heater wire.This caused an electrical short that was near the shaft tip, jaws pivot point.The physical damage observed must have occurred during clinical use.Based on the returned condition of the device, the investigation results, and the engineer evaluation, the reported failure, "failure to cut¿, was confirmed.The lot # 3000269608 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: 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: 15845807
• MDR Text Key: 306518941
• Report Number: 2242352-2022-00965
• 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: 01/10/2023

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 Expiration Date: 09/26/2023
• Device Model Number: VASOVIEWHEMPRO VH-3500
• Device Catalogue Number: C-VH-3500
• Device Lot Number: 3000269608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: 01/12/2023
• Supplement Dates FDA Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1