MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW VV6 PRO; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VH-2400

Device Problems Mechanical Problem (1384); Defective Component (2292)

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

Event Date 02/03/2023

Event Type  malfunction  

Event Description

The hospital reported vasoview 6 pro out-of-box failure.The blue toggle that moves the blade was loose and did not control the blade.The device did not work from the beginning.It was totally intact, with no damage to the cartons.A second device was used and the case was completed without further issues.No patient was involved with the device being reported.

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.

Manufacturer Narrative

Trackwise # (b)(4).Corrected section: h6-medical device ¿ problem code -changed 2292 to 1384.

Manufacturer Narrative

Trackwise#: (b)(4).The device was returned to the factory for evaluation on 02/22/2023.An investigation was conducted on 02/27/2023.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the harvesting device handle.Blood was also observed on the intact c-ring.No visual defects were observed.The cutter blade was observed to be extended, seated in between the bipolar blades.A mechanical evaluation was conducted.The blue toggle was manipulated to retract/extend the cutter blade.Upon manipulation of the toggle, the cutter blade would not retract.There were no visual defects observed that prevented the cutter from being retracted.The handle (toggle) was opened.The rocker assembly was unscrewed so the individual pieces could be examined.A microscopic investigation was conducted.The pullrod ball was observed to be out of the socket of the rocker arm, providing no connection between the two components.Due to the lack of connection, the assembly came apart when the screws were removed with no physical force used.As demonstrated in the dhr, the device undergoes the final testing described in 90509699 part 6 (tool inspection) to ensure that the assembled device functions as expected before release from the factory.Based on the returned condition of the device, the reported failure "mechanical problem" was confirmed.The dhr, shop floor paperwork was reviewed.The device lot conforms to all applicable product specifications.All device components pass 100% inspection.Per 90509699 rev ah, all bisectors are inspected to make sure that the tool extends, retracts and rotates.The bisector is also inspected to make sure that when the toggle actuates, the bisector blade extends and retracts and the toggle rocker assembly remains seated.The lot # 3000281461 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 VV6 PRO
• 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: 16441273
• MDR Text Key: 310231913
• Report Number: 2242352-2023-00156
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700239
• UDI-Public: 00607567700239
• Combination Product (y/n): N
• PMA/PMN Number: K091733
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2023

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-2400
• Device Catalogue Number: VH-2400
• Device Lot Number: 3000281461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 02/26/2023
• Supplement Dates Manufacturer Received: 03/03/2023; 06/28/2023
• Supplement Dates FDA Received: 03/22/2023; 06/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1