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

Model Number VH-4000

Device Problem Failure to Deliver Energy (1211)

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

Event Date 07/25/2023

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 tip looked frayed, did not cut or cauterize well.Not delivering energy.Used new device.No delay.No apparent harm to patient.

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

N/a.

Manufacturer Narrative

Trackwise id# (b)(4).Specific actions for the reported/analyzed failure mode are being maintained and documented under maquet's corrective and preventive action (capa) system.The device was returned to the factory for evaluation on 08/08/2023.An investigation was conducted on 08/15/2023.A visual inspection was conducted.Signs of clinical use and evidence of charred material was observed on the heater wire.The heater wire was observed to be flexed away from the hot jaw from the base of the hot jaw with detachment at the tip of the hot jaw.There were no visual defects observed on 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.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 stm2048073 rev aa.The device successfully transected tissue four (4) times.The jaws were gently cleaned of debris and char with a saline and gauze pad as indicated in the direction for use (cv000008979).No final testing was conducted due to the condition of the heater wire.Based on the results of the evaluation, the reported failures "failure to deliver energy¿ was not confirmed, however the analyzed failure "material twisted/ bent wire" was observed.The lot # 3000317188 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: 17592713
• MDR Text Key: 321677006
• Report Number: 2242352-2023-00692
• 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: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• 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: 3000317188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male