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

Model Number VH-4000

Device Problem Intermittent Continuity (1121)

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

Event Date 10/09/2023

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 vasoview hemopro 2 wasn't working in a cabg case.They switched devices power supplies and extension cables to try and remedy the issue.They finally borrowed a power supply and vasoview from their parent hospital emory and completed the case.They had the power supply on a setting of 3 and the device worked intermittently.There were no patient affects but major delays as they tried multiple vaosviews.

Event Description

N/a.

Manufacturer Narrative

Trackwise # (b)(4).Updated section: b4, g4, g7, h2, h3, h6, h10.The device was returned to the factory for evaluation on 10/17/2023.An investigation was conducted on 10/25/2023.A visual inspection was conducted.Both the harvesting device and cannula was returned for evaluation.Signs of clinical use and evidence of blood was observed both devices.There were no visual defects observed on the intact cannula.Heavy char was observed on the heater wire.The heater wire was observed to be flexed away from the hot jaw at the center of the hot jaw, remaining attached at the tip of the hot jaw, due to normal clinical use and heavy char on the heater wire.There were no visible defects observed on the intact clear silicone insulation on both the cold and hot jaws.Heavy char was observed on the clear silicone insulation on the hot jaw.An electrical evaluation was conducted.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 at level 3.0.The device did turn on and an audible sound was heard when activating the toggle.The device passed the pre-cautery test.It produced visible steam and heat during ten (10) 3-second activations.The device was tested for the safety shut down system as the device would turn on, and produced visible steam.An activation and transection capability test was performed over four (04) 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 not conducted due to the condition of the heater wire.Based on the returned condition of the device as well as the evaluation results, the reported failure "intermittent continuity" was not confirmed.The lot # 3000333703 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: 18065359
• MDR Text Key: 327284698
• Report Number: 2242352-2023-00899
• 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: 11/03/2023

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 Model Number: VH-4000
• Device Catalogue Number: VH-4000
• Device Lot Number: 3000333703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 11/06/2023
• Supplement Dates FDA Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 131 KG