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

Model Number VH-2400

Device Problem Mechanical Problem (1384)

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

Event Date 09/25/2023

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview 6 pro knive is not working from start.There is no connection with the knob on the device and the knife.There was a 10 minutes delay.Harvester opened a second kit, there was no harm to the patient.

Manufacturer Narrative

(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.

Manufacturer Narrative

Trackwise id (b)(4).Updated sections: b4, g4, g7, h2, h3, h6, h10.The device was returned to the factory for evaluation on 10/04/2023.An investigation was conducted on 10/05/2023.A visual inspection was conducted.Signs of clinical use and no evidence of blood were observed on the device.The c-ring, bisector electrodes, and bisector blade were observed to be intact with no visual defects observed.The pullrod ball from the rocker assembly was returned loose.A mechanical evaluation was conducted.The c-ring was able to be retracted and extended using the c-ring slider with no physical or visual difficulties.The bisector rod was also able to be retracted and extended within the cannula with no physical or visual difficulties; however the bisector blade was unable to be extended and retracted using the toggle.The rocker assembly was unable to be used to extend and retract the blade and did not function properly.The rocker assembly was unscrewed so the individual pieces could be examined.A microscopic investigation was conducted.The pullrod ball was returned separately and therefore 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 (b)(4) 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 and the evaluation results, the reported failure "mechanical problem" was confirmed.The lot # 3000323217 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.

Event Description

N/a.

• 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: 17941435
• MDR Text Key: 326285497
• Report Number: 2242352-2023-00860
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700239
• UDI-Public: 00607567700239
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K091733
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• 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: 3000323217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1