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

Model Number VH-4001

Device Problem Failure to Deliver Energy (1211)

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

Event Date 07/12/2023

Event Type  malfunction  

Manufacturer Narrative

Trackwise 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 while attempting to cut and seal branches the vasoview hemopro 2 (w/vasoshield) would not activate/failed to deliver energy.The power supply was set at 3.They switched out the cord and the pigtail and it still was not working.They opened another kit with no issues to complete the case.No harm to the patient.

Manufacturer Narrative

Trackwise # (b)(4).The device was returned to the factory for evaluation on 07/21/2023.An investigation was conducted on 08/02/2023.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed on the device.Evidence of charred material was also observed between the jaws.The heater wire and clear 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 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).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.68 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 results of the evaluation, the reported failure "failure to deliver energy¿ was not confirmed.The lot # 3000295249 history record review was completed.There were 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.Specific actions for the failure modes are being maintained and documented under maquet's corrective and preventive action (capa) system.

• Brand Name: HEMOPRO 2 W/VASOSHIELD
• 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: 17443959
• MDR Text Key: 320236898
• Report Number: 2242352-2023-00651
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700451
• UDI-Public: 00607567700451
• 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: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VH-4001
• Device Catalogue Number: VH-4001
• Device Lot Number: 3000295249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1