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

Model Number VH-4000

Device Problem Failure to Cut (2587)

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

Event Date 06/27/2023

Event Type  malfunction  

Event Description

The hospital reported that during the branch division phase of the endoscopic vein harvesting procedure, vasoview hemopro 2, the branches weren't separating and sealing completely.They troubleshoot the issue with cable changes and power supply with no improvement.A new hemopro device was opened and it operated normally.The case was completed without any further issues.No patient effects.

Manufacturer Narrative

Trackwise id#: (b)(4).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.

Event Description

Summary: the hospital reported that during the branch division phase of the endoscopic vein harvesting procedure, vasoview hemopro 2, the branches weren't separating and sealing completely.They troubleshoot the issue with cable changes and power supply with no improvement.A new hemopro device was opened and it operated normally.The case was completed without any further issues.No patient effects.The device will be returned.

Manufacturer Narrative

Trackwise # (b)(4).Corrected section: d4-exp.Date- date corrected.The device was returned to the factory for evaluation on 08/07/2023.An evaluation was conducted on 08/10/2023.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed on the device.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.69 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 cut" was not confirmed.The lot # 3000314870 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: 17399988
• MDR Text Key: 320624375
• Report Number: 2242352-2023-00610
• 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: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• 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: 3000314870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK.; UNKNOWN.