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

Model Number	VH-2400
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The hospital reported that during an endoscopic vessel harvesting procedure, vasoview 6 pro knife did not cut properly.A new device was used to complete the procedure.There was a 5-minute delay.There was no patient harm.
Additional Manufacturer Narrative
Tw # (b)(4).Corrected section: d4 udi#.The device was returned to the factory for evaluation on 09/11/2024.An investigation was conducted on 09/30/2024.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There were no visual defects observed on the intact c-ring or the intact bipolar blades.The blue toggle was manipulated to retract and extend the cutter blade.There were no visual defects observed on the intact cutter blade.An electrical evaluation was conducted.A pre-cautery test was performed and repeated 10 times over a 10 minute period according to the procedure in the instructions for use (cv000001597).The device passed the pre-cautery test with a reference generator (recommended setting of 18) and reference bipolar cord.The bipolar cord connection was manipulated during activation.The device did produce steam and the saline did ¿boil¿ on the test gauze each time.To test the ability of the device to cut, a cautery test was performed on artificial vessel.The device was able to cut reference vessels cleanly.Based on the returned condition of the device as well as the evaluation results, the reported failure "failure to cut" was not confirmed.The lot # 3000361645 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
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 20291760
• Report Number: 2242352-2024-0001061
• Device Sequence Number: 7171063
• Product Code: GEI
• UDI-Device Identifier: 00607567700239
• UDI-Public: (01)00607567700239(10)3000361645(17)251221
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K091733
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/21/2025
• Device Model Number: VH-2400
• Device Catalogue Number: VH-2400
• Device Lot Number: 3000361645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown